Medical Device Technologies, Inc.
Gainesville, FL, US
Medical Device Technologies, Inc. appears in FDA device records in Gainesville, FL. FDA records list 46 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 50 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 46 510(k) clearances for Medical Device Technologies, Inc. between 1992 and 2010. The busiest year on record is 1998, with 22. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 2 |
| 1994 | 1 |
| 1995 | 1 |
| 1996 | 3 |
| 1997 | 1 |
| 1998 | 22 |
| 1999 | 3 |
| 2000 | 3 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 2 |
| 2005 | 3 |
| 2006 | 1 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K101832 | BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT | KNW | Substantially Equivalent | |
| K053518 | INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR | NEU | Substantially Equivalent | |
| K051421 | INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR | NEU | Substantially Equivalent | |
| K050873 | CANALIZER HYDROPHILIC GUIDE WIRE | DQX | Substantially Equivalent | |
| K043523 | INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE | KNW | Substantially Equivalent | |
| K042464 | V-CORE FULL CORE BREAST BIOPSY INSTRUMENT | KNW | Substantially Equivalent | |
| K040427 | FIBREX CATHETER PATENCY DEVICE | FOZ | Substantially Equivalent | |
| K031442 | PBN GUIDEWIRES | DQX | Substantially Equivalent | |
| K021606 | EN-SNARE ENDOVASCULAR SNARE AND CATHETER | MMX | Substantially Equivalent | |
| K011790 | MICROCRUISER PLUS INTRODUCER SET | DYB | Substantially Equivalent | |
| K000620 | PBN FALLOPIAN TUBE CATHETER SYSTEM | MDG | Substantially Equivalent | |
| K002416 | GOLDEN-RULE SCALING CATHETER | DQO | Substantially Equivalent | |
| K000433 | PBN HYSTERO-SALPINGOGRAPHY CATHETER SET | LKF | Substantially Equivalent | |
| K990808 | PBN DILATORS | FGE | Substantially Equivalent | |
| K990839 | TRU-CORE I REUSABLE BIOPSY INSTRUMENT | KNW | Substantially Equivalent | |
| K991097 | PBN DRAINAGE CATHETER GUIDEWIRES | KNY | Substantially Equivalent | |
| K982960 | MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT | KNW | Substantially Equivalent | |
| K982085 | MEDICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSALE SEMI-AUTOMATIC BIOPDY INSTRUMENT | KNW | Substantially Equivalent | |
| K980193 | MANAN GENERAL UTILITY DRAINAGE CATHETER | LJE | Substantially Equivalent | |
| K980192 | MANAN NEPHROSTOMY DRAINAGE CATHETER | LJE | Substantially Equivalent | |
| K980372 | MANAN VS ACCESS NEEDLE/SET | FGE | Substantially Equivalent | |
| K980227 | MANAN GALACTOGRAPHY KIT | FMI | Substantially Equivalent | |
| K981258 | MANAN MALECOT BASKET DRAINAGE CATHETER | FEW | Substantially Equivalent | |
| K981229 | MANAN MANTA CATHETER FIXATION DISK | KNY | Substantially Equivalent | |
| K974745 | MANAN GWI GUIDE WIRE INTRODUCER | DRC | Substantially Equivalent | |
| K974743 | MANAN | DRC | Substantially Equivalent | |
| K974742 | MANAN POTTS-COURNAND NEEDLE | DRC | Substantially Equivalent | |
| K980452 | MANAN LIVER BIOPSY KIT | KNW | Substantially Equivalent | |
| K980226 | MANAN PRO-MAG AUTOMATIC BIOPSY SYSTEM | KNW | Substantially Equivalent | |
| K980191 | MANAN BILIARY DRAINAGE CATHETER | FGE | Substantially Equivalent | |
| K980196 | MD TECH BIOPSY SET FOR BONE AND BONE MARROW | KNW | Substantially Equivalent | |
| K980122 | MANAN SOFT TISSUE BIOPSY NEEDLES | KNW | Substantially Equivalent | |
| K980005 | MANAN D BAG | EXF | Substantially Equivalent | |
| K980004 | MANAN GENERAL PURPOSE INTRODUCER NEEDLE | KNW | Substantially Equivalent | |
| K974815 | MANAN(TM) INTRODUCER SHEATH/NEEDLE | FGE | Substantially Equivalent | |
| K974814 | MANAN(TM) SUPER-CORE BIOPSY NEEDLES | KNW | Substantially Equivalent | |
| K974766 | MANAN TECHNA-CUT ASPIRATION NEEDLE | KNW | Substantially Equivalent | |
| K974741 | MANAN ACCURA NEEDLE | GAA | Substantially Equivalent | |
| K965037 | CELL RECOVERY SYSTEM | FDX | Substantially Equivalent | |
| K962969 | MEDICAL DEVICE TECHNOLOGIES, INC.ULTRA | KNW | Substantially Equivalent | |
| K961959 | MD TECH BIOPSY SET FOR BONE AND BONE MARROW | GAA | Substantially Equivalent | |
| K960004 | CELL RECOVERY SYSTEM | FDX | Substantially Equivalent | |
| K944522 | MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT | IWJ | Substantially Equivalent | |
| K944837 | MEDICAL DEVICE TECHNOLOGIES MANUAL BIOPSY NEEDLE | KNW | Substantially Equivalent | |
| K921418 | ULTRA-CORE BIOPSY NEEDLES | DWO | Substantially Equivalent | |
| K915417 | KOPAN'S TARGET | GAA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNYAccessories, Catheter, G-U
- EXFBag, Bile Collecting
- LKFCannula, Manipulator/Injector, Uterine
- DQOCatheter, Intravascular, Diagnostic
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- FEWCatheter, Malecot
- LJECatheter, Nephrostomy
- MMXDevice, Percutaneous Retrieval
- FDXEndoscopic Cytology Brush
- KNWInstrument, Biopsy
- DYBIntroducer, Catheter
- NEUMarker, Radiographic, Implantable
- GAANeedle, Aspiration And Injection, Disposable
- DWONeedle, Biopsy, Cardiovascular
- FMINeedle, Hypodermic, Single Lumen
- FGEStents, Drains And Dilators For The Biliary Ducts
- IWJSystem, Applicator, Radionuclide, Manual
- MDGSystem, Intrafallopian Cannula
- DRCTrocar
- DQXWire, Guide, Catheter
Recall records
Showing 25 of 50| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0246-2012 | Angiotech***TLok Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - Specimen Label; 1 - Stirring Rod; 1 - 8ga x 4 Bone Marrow Needed J Type; 1 16ga x 2.688 Bone Marrow Needle I Type; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 10 - Micro Slides - Frosted end; 1 - Fenestrated Drape; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 - 4mL Specimen Tube w/EDTA; 1 - Probe Guide; 1 - Obturator; 1- Male Luer Cap; 1 T-Lok Extraction Cannula; 1 - Towel; 1 - 2"x3" ADH Dressing; 1 - 6/7 Dram Snap Cap Vials-Amber; 1 -Glass Slide Poly Bag; 1 - CSR Wrap***Catalog Number: BMT0804TL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity. | Terminated | ||
| Z-0245-2012 | Angiotech*** Custom Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - Fenestrated Drape; 1 - 21ga x 1-1/2" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 25ga x 5/8" Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - Probe Guide; 1 Obturator; 1 - Male Luer Cap; 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - 2"x 3" ADH Dressing; 1 - Towel; 1 15ga x 4" Bone Marrow Needle "I" Type; 1 - 2% Lidocaine (10mL); 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - T-Lok Extraction Cannula; 1 - CSR Wrap***Catalog Number: CB0355TL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity. | Terminated | ||
| Z-0244-2012 | Angiotech*** Custom Bone Marrow Tray for Louis Weiss Memorial Hospital***1 - #11 Mini Scalpel; 1 - 20ga x 1-1/2" Needle; 1 - 21ga x 1-1/2" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 25ga x 5/8" Needle; 1 - 1cc Syringe L/L; 1 - 5cc Syringe L/L; 2 - 10cc Syringe L/L; 1 Needle Safety Foam Block, Large; 1 - Fenestrated Drape; 1 - Male Luer Cap; 1 - CSR Wrap; 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 - 4" x 4" Sponges in stacks of 5; 1 - 2"x 3" ADH Dressing; 1 - Towel; 4 Alcohol Swab Sticks; 20 - Micro Slides - Frosted end; 1 - T-Lok Extraction Cannula; 1 - 2% Lidocaine (10mL); 1 - 11ga x 4 Bone Marrow Needle J Type; 1 - Probe Guide; 1 Obturator.***Catalog Number: CB0318TL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity. | Terminated | ||
| Z-0243-2012 | Angiotech***General Biopsy Tray*** 1 - 20cc Syringe L/L; 1 - 10cc Syringe L/L; 1 - 5cc Syringe L/L; 1- 25ga x 5/8" Needle; 1 - 21ga x 1-1/2" Needle;1- 19ga x 1-1/2" Filter Needle; 1 - 10% Povidone Iodine Swab Sticks (3/Pkg); 1 - 1% Lidocaine (5mL); 1 - #11 Mini Scalpel; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - " x 3" Bandage; 2 - Towel; 1 - Fenestrated Drape; 2 - 15mL Specimen Tube; 2 - Specimen Label; 1 - Ruler; 1 - CSR Wrap***Catalog Number: GUTS1000***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity. | Terminated | ||
| Z-0242-2012 | Angiotech***Custom General Biopsy Tray for Lenox Hill Hospital*** 4 -Towel; 1 -19ga x 1-1/2" Filter Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - Needle Safety Foam Block; 2 - 10cc Syringe L/L; 1 - Ruler; 2 4" x 4" Sponges in stacks of 5; 1 - " x 3" Bandage; 1 - 10% Povidone Iodine Swab Sticks (3/Pkg); 2 -1% Lidocaine (5mL); 1 - CSR Wrap***Catalog Number: CG0305***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity. | Terminated | ||
| Z-0241-2012 | Angiotech***Custom General Biopsy Tray for Lenox Hill Hospital*** 1 - #11 Mini Scalpel; 1 - Fenestrated Drape; 1 - 19ga x 1-1/2" Filter Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - Needle Safety Foam Block; 2 - 10cc Syringe L/L; 4 - Towel; 1 - Ruler; 1 - 4" x 4" Sponges in stacks of 5; 1 - " x 3" Bandage; 1 - 10% Povidone Iodine Swab Sticks (3/Pkg); 1 - 2% Lidocaine (10mL) ; 1 - CSR Wrap***Catalog Number: CG0287***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity. | Terminated | ||
| Z-0240-2012 | Angiotech***Custom General Biopsy Tray for St. Johns Mercy Hospital*** 1 - #11 Mini Scalpel; 1 - Fenestrated Drape; 1 -21ga x 1-1/2 Needle; 1 - 25ga x 5/8 Needle; 1 - 19ga x 1-1/2 Filter Needle; 1 - 10% Povidone Iodine Swab Sticks (3/Pkg); 2 - 1% Lidocaine (5mL); 1 - Specimen Label; 1 - 10cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - 3 x 3 Sponges in stacks of 5 (4-Ply); 1 - x 3 Bandage; 1 - Towel; 1 - CSR Wrap***Catalog Number: CG0236***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity. | Terminated | ||
| Z-0239-2012 | Angiotech***Custom General Biopsy Tray for Palos Community Hospital*** 1 - #11 Mini Scalpel; 1 - Fenestrated Drape; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 -18ga x 5cm Blunt Needle; 2 - 10cc Syringe L/L; 1 - 10% Povidone Iodine Swab Sticks (3/Pkg); 2 - 1% Lidocaine (5mL); 1 - Ruler; 1 - Screw Type Needle Stop; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - Alcohol Swab Sticks; 1 - 3/4" x 3" Bandage; 2 - Towel; 1 - Specimen Label; 1 - Needle Safety Foam Block, Small; 1 - CSR Wrap***Catalog Number: CG0188***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity. | Terminated | ||
| Z-0238-2012 | Angiotech***Custom General Biopsy Tray for OMA North of Oklahoma City*** 1 - 60cc Syringe; 2 - 10cc Syringe L/L; 1 -18ga x 1-1/2" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 20ga x 1-1/2" Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 50cm Extension Tube; 1 - 10% Povidone Iodine Swab Sticks (3Pkg); 1 - 1% Lidocaine (5mL); 1 - 3" x 3" Sponges is stacks of 5 (4-Ply); 1 - Fenestrated Drape; 1 - Towel; 1 - CSR Wrap***Catalog Number: CG0072***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity. | Terminated | ||
| Z-0237-2012 | Angiotech***Custom General Biopsy Tray for University of Rochester Medical Center***1 - Fenestrated Drape; 1 - 19ga x 1-1/2" Filter Needle; 1 - 22ga x 1-1/2" Needle; 1 - 25ga x 1-1/2" Needle; 1 - 10cc Syringe L/L; 1 - 10% Providone Iodine Swab Sticks (3/Pkg.); 2 - 1% Lidocaine (5mL); 1 - " x 3" Bandage; 1 - Towel; 1 - CSR Wrap; 1 - Lidocaine Insert; 1 - Ruler with Protractor; 1 - 4" x 4" Sponges in stacks of 5***Catalog Number: CG00552***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity. | Terminated | ||
| Z-0236-2012 | Angiotech***Custom General Biopsy Tray for Emory University Hospital*** 1 - CSR Wrap 48" x 48"; 1 - Fenestrated Drape; 4 -10cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - Chloraprep Applicator (3ml); 2 - 2% Lidocaine (10mL); 2 - Towel; 1 - " x 3" Bandage; 1 - Needle Safety Foam Block, Large; 6 - Specimen Label; 1 - Scalpel #11; 1 - 25ga x 5/8" Needle w/ Safety Glide; 1 - 21ga x 1-1/2" Needle w/ Safety Glide; 1 - 5 Curved Hemostat; 2 - 4" x 4" Sponges in stacks of 5; 1 -19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - Ruler with Protractor***Catalog Number: CG00548***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity. | Terminated | ||
| Z-0235-2012 | Angiotech***Custom Bone Marrow Tray for High Point Regional Hospital*** 1 - #11 Mini Scalpel; 1 - Fenestrated Drape; 1 - 20ga x 1-1/2" Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle;1 - 5cc Syringe L/L; 1 - 10cc Syringe L/L; 3 - 20cc Syringe L/L; 1 - Probe Guide; 1 - 10% Povidone Iodine Swab Sticks (3/Pkg); 3 - 4" x 4" Sponges in stacks of 5; 1 - Towel; 1 - 2" x 3" ADH Dressing; 1 - Specimen Label; 1 - Obturator; 1 - Male Luer Cap; 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - T-Lok Extraction Cannula; 1 - CSR Wrap***Catalog Number: CB0387TL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity. | Terminated | ||
| Z-0234-2012 | Angiotech***Custom Bone Marrow Tray for Hackensack University Medical Center*** 1 - Fenestrated Drape; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle;1 - 5cc Syringe L/L; 2 -10cc Syringe L/L; 1 - Male Luer Cap; 1 - Glass Slide Poly Bag; 1 - 10% Povidone Iodine Swab Sticks (3/Pkg); 1 - 1% Lidocaine (5mL); 1 - 2" x 3" ADH Dressing; 1 - Towel; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 10 - Micro Slides Frosted end; 1 - 15ga x 2.688" Bone Marrow Needle "I" Type; 1 - CSR Wrap***Catalog Number: CB0370***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity. | Terminated | ||
| Z-0233-2012 | Angiotech***Custom Bone Marrow Tray*** 1 - #11 Mini Scalpel; 1 -Fenestrated Drape; 1 - 21ga x 1-1/2" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 25ga x 5/8" Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - Probe Guide; 1 - Obturator; 1 - Male Luer Cap; 1 - 10% Providone Iodine Swab Sticks (3/Pkg.); 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - 2" x 3" ADH Dressing; 1 -Towel; 1 - 15ga x 4" Bone Marrow Needle "I" Type; 1 - 2% Lidocaine (10mL); 1 - 8ga x 4" Bone Marrow Needle "J" Type; 1 - T_Lok Extraction Cannula; 1 - CSR Wrap***Catalog Number: CB0356TL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity. | Terminated | ||
| Z-0232-2012 | Angiotech***Custom Bone Marrow Tray for Tyler Hematology Oncology*** 1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 25ga x 5/8" Needle; 1 - 25ga x 1-1/2" Needle; 1 - 10cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - Male Luer Cap; 1 - CSR Wrap; 1 - 10% Providone Iodine Swab Sticks (3/Pkg.); 1 - 4" x 4" Sponges in stacks of 5; 1 - 2" x 3" ADH Dressing; 2 - Towel; 1 - 2% Lidocaine (10mL); 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - Probe Guide; 1 - Obturator; 1 - T-Lok Extraction Cannula; ***Catalog Number: CB0202TL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity. | Terminated | ||
| Z-0231-2012 | Angiotech***Custom Bone Marrow Tray for Kaiser Foundation Hospitals*** 1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 25ga x 1-1/2" Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - Male Luer Cap; 1 - CSR Wrap; 1 - 10% Providone Iodine Swab Sticks (3/Pkg.); 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - 2" x 3" ADH Dressing; 1 - Towel; 1 - Stirring Rod; 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - Probe Guide; 1 - Obturator; 1 - T-Lok Extraction Cannula; ***Catalog Number: CB0187TL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity. | Terminated | ||
| Z-0230-2012 | Angiotech***Custom Bone Marrow Tray*** 1 - #11 Mini Scalpel; 1 - 20ga x 1-1/2" Needle; 1 - 23ga x 1" Needle; 1 - 18ga x 3-1/2" Needle; 1 - 25ga x 5/8" Needle; 3 - 10cc Syringe L/S; 2 - 1% Lidocaine (5mL); 1 - Male Luer Cap; 1 - Fenestrated Drape; 1 - CSR Wrap; 1 10% Providone Iodine Swab Sticks (3/Pkg.); 3 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 2" x 3" ADH Dressing; 1 - Towel; 1 - 15ga x 2.688" Bone Marrow Needle "I" Type; 1 - 11ga x 4" Bone Marrow Needed "J" Type; 1 - Probe Guide; 1 - Obturator; 1 - T-Lok Extraction Cannula***Catalog Number: CB0181TL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity. | Terminated | ||
| Z-0229-2012 | Angiotech***Custom Bone Marrow Tray for University of CA, Davis*** 1 - 10cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - 19ga x 1-1/2" Filter Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 8ga x 4" Bone Marrow Needed "J" Type; 1 15ga x 4" Bone Marrow Needle "I" Type; 1 - T- Lok Extraction Cannula; 1 - 10% Providone Iodine Swab Sticks (3/Pkg.); 1 - Probe Guide; 1 - Obturator; 2 - 1% Lidocaine (5mL); 1 - #11 Mini Scalpel; 2 - 4" x 4" Sponges in stacks of 5; 1 - 2" x 3" ADH Dressing; 1 - Towel; 1 - Fenestrated Drape; 1 - Male Luer Cap; 1 - CSR Wrap***Catalog Number: CB0140TL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity. | Terminated | ||
| Z-0228-2012 | Angiotech***Custom Bone Marrow Tray for University of Chicago*** 2- 20ga x 1 " Safety Needle; 1 21ga x 1-1/2" Safety Needle; 1 25ga x 5/8" Safety Needle; 1 - 10cc Syringe L/L; 2 - 20cc Syringe L/L; 3 - 4" x 4" Sponges in stacks of 5; 2 - 3" x 3" Sponges in stacks of 5; 1 - CSR Wrap; 2 - Fenestrated Drape; 1 - 5" Hemostat Straight Mosquito; 1 - #11 Retractable Scalpel; 1 - 8ga x 4" Bone Marrow Needle "J" Type; 1 - 16ga x 2.688" Bone Marrow Needle "I" Type; 1 - Probe Guide; 1 - Male Luer Cap; 1 - T-Lok Extraction Cannula; 1 - Obturator; 2 - Petri Dish***Catalog Number: CB00541TL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity. | Terminated | ||
| Z-0227-2012 | Angiotech***Custom Bone Marrow Tray for New York Hospital/Cornell Medical Center*** 1 - 18ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 22ga x 1-1/2" Needle; 1 - 21ga x 1-1/2" Needle; 1 - 20cc Syringe L/L; 1 - 10cc Syringe L/L; 2 - 10cc Syringe L/S; 1 - Obturator; 1 - Male Luer Cap; 20 - Micro Slides - Frosted end; 1 - T-Lok Extraction Cannula; 1 - 11ga x 4" Bone Marrow Needle "J" Type; 4 - Ampule Breaker; 2 - 10% Povidone Iodine Swab Sticks (3/Pkg); 2 - 4mL Specimen Tube w/EDTA; 1 - Long Handle Scalpel; 4 - 3" x 3" Sponges in stacks of 5 (4-Ply); 4 -Alcohol Swab Sticks; 4 - 1% Lidocaine (5mL); 1 - 2"x3" ADH Dressing; 3 - Towels; 1 - Probe Guide; 1 - Fenestrated Drape; 1 - CSR Wrap; 1 - 19ga x 1-1/2" Filter Needle ***Catalog Number: CB0033TL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity. | Terminated | ||
| Z-0226-2012 | Angiotech***Bone Marrow Tray***1 - 20cc Syringe L/L; 1 - 5cc Syringe L/L; 1 - 19ga x 1-1/2" Filter Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 16ga x 2.688" Bone Marrow Needle "I" Type; 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 - 4mL Specimen Tube w/EDTA; 10 - Micro Slides - Frosted end; 1 - 1% Lidocaine (5mL); 1 - #11 Mini Scalpel; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - 2"x3" ADH Dressing; 1 - Towel; 1 - Fenestrated Drape; 1 - Amber Specimen Bottle w/ Cap; 1 - Specimen Label; 1 - Stirring Rod; 1 - CSR Wrap***Catalog Number: BMT1601***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity. | Terminated | ||
| Z-0225-2012 | Angiotech***Bone Marrow Tray***1 - 20cc Syringe L/L; 1 - 5cc Syringe L/L; 1 - 19ga x 1-1/2" Filter Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 15ga x 2.688" Bone Marrow Needle "I" Type; 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 - 4mL Specimen Tube w/EDTA; 10 - Micro Slides - Frosted end; 1 - 1% Lidocaine (5mL); 1 - #11 Mini Scalpel; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - 2"x3" ADH Dressing; 1 - Towel; 1 - Fenestrated Drape; 1 - Amber Specimen Bottle w/ Cap; 1 - Specimen Label; 1 - Stirring Rod; 1 - CSR Wrap***Catalog Number: BMT1501***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity. | Terminated | ||
| Z-0224-2012 | Angiotech***T-Lok Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - 16ga x 2.688" Bone Marrow Needle "I" Type; 1 - 6/7 Dram Snap Cap Vials-Amber; 1 - Specimen Label; 1 - 2"x3" ADH Dressing; 10 - Micro Slides - Frosted end; 1 - Fenestrated Drape; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 - 4mL Specimen Tube w/EDTA; 1 Probe Guide; 1 -Obturator; 1 - Male Luer Cap; 1 T-Lok Extraction Cannula; 1 - Towel; 1 - Stirring Rod; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - Glass Slide Poly Bag; 1 - CSR Wrap***Catalog Number: BMT1104TL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity. | Terminated | ||
| Z-0223-2012 | Angiotech***T-Lok Bone Marrow Tray w/ Safety Needles***1 - #11 Retractable Scalpel; 1 - 21ga x 1-1/2" Safety Needle; 1 - 25ga x 5/8" Safety Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - Specimen Label; 5 - 3" x 3" Sponges (4-Ply); 1 - CSR Wrap; 1 - 6/7 Dram Snap Cap Vials-Amber; 1 - Stirring Rod; 1 - Fenestrated Drape; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 - 4mL Specimen Tube w/EDTA; 1 - Probe Guide; 1 -Obturator; 1 - Male Luer Cap; 1 - T-Lok Extraction Cannula; 1 - 2"x3" ADH Dressing; 10 - Micro Slides - Frosted end; 1 - Towel; 3 - NeedleVISE***Catalog Number: BMT1104STL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity. | Terminated | ||
| Z-0222-2012 | Angiotech***T-Lok Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - Specimen Label; 1 - Stirring Rod; 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - 15ga x 2.688" Bone Marrow Needle "I" Type; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 10 - Micro Slides - Frosted end; 1 - Fenestrated Drape; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 1 - Probe Guide; 1 - Obturator; 1 - Male Luer Cap; 1 - T-Lok Extraction Cannula; 2 - 4mL Specimen Tube w/EDTA; 1 - Towel; 1 - 2"x3" ADH Dressing; 1 - 6/7 Dram Snap Cap Vials-Amber; 1 -Glass Slide Poly Bag; 1 - CSR Wrap; ***Catalog Number: BMT1104BTL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity. | Terminated |
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