Instrumed International Inc dba Avalign German Specialty Instruments
Schaumburg, IL, US
Instrumed International Inc dba Avalign German Specialty Instruments appears in FDA device records in Schaumburg, IL. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 38 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Instrumed International Inc dba Avalign German Specialty Instruments carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Instrumed International, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 7 510(k) clearances for Instrumed International Inc dba Avalign German Specialty Instruments between 2004 and 2010. The busiest year on record is 2009, with 2. The most recent is 2010, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 2 |
| 2010 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K100518 | INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 | DWP | Substantially Equivalent | |
| K100517 | INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX | HDA | Substantially Equivalent | |
| K092840 | INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL | HCZ | Substantially Equivalent | |
| K092544 | INSTRUMED VASCULAR CLAMPS | DXC | Substantially Equivalent | |
| K081651 | INSTRUMED RONGEUR | HAE | Substantially Equivalent | |
| K071771 | INSTRUMED RETRACTORS | GZT | Substantially Equivalent | |
| K040855 | INSTRUMED LAPAROSCOPE AND ACCESSORIES | GEI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1421101 | 1421101 | Instrumed International Inc dba Avalign German Specialty Instruments | 626 Cooper Ct, SCHAUMBURG, IL 60173 US | 2026 | and 231 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EHOBar, Preformed
- EMLChisel, Bone, Surgical
- EMMChisel, Osteotome, Surgical
- FZOChisel, Surgical, Manual
- FFNClamp, Non-Electrical
- DXCClamp, Vascular
- EKTCurette, Endodontic
- EMKCurette, Surgical, Dental
- FZSCurette, Surgical, General Use
- FZTCutter, Surgical
- DWPDilator, Vessel, Surgical
- EMJElevator, Surgical, Dental
- EMIFile, Bone, Surgical
- EFLForceps, Dressing, Dental
- EMHForceps, Rongeur, Surgical
- EMGForceps, Tooth Extractor, Surgical
- BWBForceps, Tube Introduction
- EILGauge, Depth, Instrument, Dental
- FZXGuide, Surgical, Instrument
- FZYHammer, Surgical
- EJBHandle, Instrument, Dental
- FHQHolder, Needle, Gastroenterologic
- EKDInstrument, Cutting, Operative
- ECPInstrument, Ligature Tucking, Orthodontic
- DZNInstruments, Dental Hand
- DWSInstruments, Surgical, Cardiovascular
- EMFKnife, Surgical
- CCWLaryngoscope, Rigid
- FHNLigator, Hemorrhoidal
- FCWLight Source, Fiberoptic, Routine
- FSTLight, Surgical, Fiberoptic
- FTZLocator, Magnetic
- FZZMarker, Skin
- FTXMirror, General & Plastic Surgery
- EAXMirror, Mouth
- EOBNasopharyngoscope (Flexible Or Rigid)
- FHRNeedle, Gastro-Urology
- EJYPliers, Operative
- FGMProbe And Director, Gastro-Urology
- ECSPusher, Band, Orthodontic
- GACRasp, Surgical, General & Plastic Surgery
- GADRetractor
- EIGRetractor, All Types
- FGNRetractor, Non-Self-Retaining
- FFORetractor, Self-Retaining
- FHLScoop
- FBSSound, Metal, Interconnected
- FBXSound, Urethral, Metal Or Plastic
- EQHSource, Carrier, Fiberoptic Light
- GAFSpatula, Surgical, General & Plastic Surgery
- FXGSpecula Accessories
- EPYSpeculum, Ent
- FXESpeculum, Non-Illuminated
- FFQSpeculum, Rectal
- GAHStylet, Surgical, General & Plastic Surgery
- EJISyringe, Cartridge
- FTYTape, Measuring, Rulers And Calipers
- EYRTourniquet, Gastro-Urology
- FSMTray, Surgical, Instrument
- EZOUrethrotome
Recall records
Showing 25 of 38| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0559-2015 | Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and are sold under the Ambler Surgical brand name. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. | Class II | Terminated | |
| Z-0558-2015 | Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and are sold under the Millennium Surgical, Symmetry Surgical, Accutome, Boss Instruments, and Medline Industries brand names. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. | Class II | Terminated | |
| Z-0557-2015 | Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. | Class II | Terminated | |
| Z-0556-2015 | CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Millennium Surgical, Medfix International, CareFusion, Boss Instruments, Medline Industries, Surgical Direct, and Teleflex Medical brand names. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. | Class II | Terminated | |
| Z-0555-2015 | Gardner-Wells wrenches are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the CareFusion brand name. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. | Class II | Terminated | |
| Z-0554-2015 | Traction tong replacement screws, non-springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Boss Instruments, and Stealth Surgical brand names. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. | Class II | Terminated | |
| Z-0553-2015 | Titanium fixation screws, springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the Millennium Surgical, Boss Instruments, Stealth Surgical, and CareFusion brand names. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. | Class II | Terminated | |
| Z-0552-2015 | Lock nuts for titanium traction tongs are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Millennium Surgical, Boss Instruments, and Stealth Surgical brand names | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. | Class II | Terminated | |
| Z-0551-2015 | Replacement screw non-springloaded traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the CareFusion, Boss Instruments, Millennium Surgical, Prezio Health, and Stealth Surgical brand names. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. | Class II | Terminated | |
| Z-0550-2015 | Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the Millenium Surgical, Echo Instruments, Adler Instrument, Surgical Direct, Stealth Surgical, CareFusion, and Boss Instruments brand names. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. | Class II | Terminated | |
| Z-0549-2015 | Galt trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion brand name. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. | Class II | Terminated | |
| Z-0548-2015 | Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, Stealth Surgical, and Boss Instruments brand names. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. | Class II | Terminated | |
| Z-0547-2015 | McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. | Class II | Terminated | |
| Z-0546-2015 | D'errico perforator drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Teleflex Medical, and CareFusion brand names. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. | Class II | Terminated | |
| Z-0545-2015 | McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Phoenix Instruments, Stealth Surgical, CareFusion, and Boss Instruments brand names. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. | Class II | Terminated | |
| Z-0544-2015 | Hudson burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, CareFusion, Boss Instruments, and Medline Industries brand names. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. | Class II | Terminated | |
| Z-0543-2015 | Cushing burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Medfix International and Stealth Surgical brand names. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. | Class II | Terminated | |
| Z-0542-2015 | Cushing perforating drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments, Symmetry Surgical, Medfix International, Stealth Surgical, and CareFusion brand names. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. | Class II | Terminated | |
| Z-0541-2015 | Hudson cerebellar extensions are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments brand name. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. | Class II | Terminated | |
| Z-0540-2015 | Hudson braces are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Teleflex Medical, Boss Instruments, Symmetry Surgical, and CareFusion brand names. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. | Class II | Terminated | |
| Z-0539-2015 | Manual trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Millennium Surgical, Symmetry Surgical, Medline Industries, CareFusion, Boss Instruments, and Surgical Direct brand names. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. | Class II | Terminated | |
| Z-0538-2015 | A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, Surgipro, Teleflex Medical, Boss Instruments, Symmetry Surgical, Phoenix Instruments, GICAL, and CareFusion brand names. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. | Class II | Terminated | |
| Z-0537-2015 | Manual bunnell cranial drills are bone cutting and drilling instruments that are used without a power source on a patient's skull sold under the Boss Instruments brand name. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. | Class II | Terminated | |
| Z-0536-2015 | An external vein stripper is an extravascular device used to remove a section of a vein sold under the Symmetry Surgical, CareFusion, Boss Instruments, Phoenix Instruments, Autobahn Surgical, Echo Instruments, Millennium Surgical, B.B.M. Surgical Instruments, Stealth Surgical, Medline Industries, Medsaver M S I Precision, and Surgical Direct brand names. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. | Class II | Terminated | |
| Z-0535-2015 | A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula sold under the Symmetry Surgical, CareFusion, and Ambler Surgical brand names. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain