Remington Medical
Alpharetta, GA, US
REMINGTON MEDICAL appears in FDA device records in Alpharetta, GA. FDA records list 19 510(k) clearances between and , no PMA records and 4 registered establishments. As of , FDA records show 20 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 19 510(k) clearances for Remington Medical between 1993 and 2025. The busiest year on record is 1993, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 2 |
| 1994 | 1 |
| 1995 | 2 |
| 1997 | 2 |
| 1998 | 2 |
| 1999 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2013 | 1 |
| 2015 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251904 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01) | DPW | Substantially Equivalent | |
| K241583 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01) | DPW | Substantially Equivalent | |
| K211589 | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger | DPW | Substantially Equivalent | |
| K212065 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger | DPW | Substantially Equivalent | |
| K191315 | Remington Medical, Inc. Automatic Cutting Needle (NAC) | KNW | Substantially Equivalent | |
| K150266 | Remington Medical Inc. Tuohy Epidural Needles | BSP | Substantially Equivalent | |
| K130282 | REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT | KNW | Substantially Equivalent | |
| K050884 | ADAPTER CABLE | DTA | Substantially Equivalent | |
| K040266 | CORE NEEDLE BIOPSY | KNW | Substantially Equivalent | |
| K990428 | DRAINAGE BAG | EXF | Substantially Equivalent | |
| K983621 | NEEDLE GUIDE | IZH | Substantially Equivalent | |
| K982401 | PROSTATE BIOPSY NEEDLE | KNW | Substantially Equivalent | |
| K972134 | BAG DECANTER | LHI | Substantially Equivalent | |
| K971968 | SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97) | DSA | Substantially Equivalent | |
| K953812 | GAUZE SPONGE | KHR | Substantially Equivalent | |
| K946060 | REMINGTON MEDICAL DISPOSABLE FLUORO/EQUIPMENT COVER MODEL RMI8 | KKX | Substantially Equivalent | |
| K940467 | REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-601 | DTE | Substantially Equivalent | |
| K932370 | REMINGTON MEDICAL DISPOS TEAR-AWAY VASC INTRO SET | DYB | Substantially Equivalent | |
| K922009 | DISPOSABLE SURGICAL EXTENSION CABLE MODEL S-101 | DSA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3001676837 | 3001676837 | REMINGTON MEDICAL | 401 Bentley St, Markham Ontario L3R9T2 CA | 2026 | |
| 1056553 | 1000132370 | REMINGTON MEDICAL, INC. | 6830 Meadowridge Ct, ALPHARETTA, GA 30005 US | 2026 | and 33 more, listed in full below |
| 3007014520 | 3007014520 | Remington Medical, Inc. | 6245 Shiloh Road, Alpharetta, GA 30005 US | 2026 | and 23 more, listed in full below |
| 3009265194 | 3009265194 | Remington Medical, S.A. | Zona Franca Industrial de las Americas, Edificio B-11, Santo Domingo Este 15001 DO | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KHRAbsorber, Saliva, Paper
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- EXFBag, Bile Collecting
- HTWBit, Drill
- PMLBone Cement, Posterior Screw Augmentation
- IKDCable, Electrode
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- DRACatheter, Steerable
- BSKCuff, Tracheal Tube, Inflatable
- KYXDispenser, Liquid Medication
- KKXDrape, Surgical, Antimicrobial
- GXYElectrode, Cutaneous
- GXZElectrode, Needle
- IKNElectromyograph, Diagnostic
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- ORZEyelid Thermal Pulsation System
- MQVFiller, Bone Void, Calcium Compound
- DPWFlowmeter, Blood, Cardiovascular
- KNWInstrument, Biopsy
- LFLInstrument, Ultrasonic Surgical
- DWSInstruments, Surgical, Cardiovascular
- OWBInterventional Fluoroscopic X-Ray System
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- PHMIntervertebral Fusion Device With Bone Graft, Thoracic
- DYBIntroducer, Catheter
- FSTLight, Surgical, Fiberoptic
- FZZMarker, Skin
- ISAMassager, Therapeutic, Electric
- GAANeedle, Aspiration And Injection, Disposable
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- MIJNeedle, Tumor Localization
- HAWNeurological Stereotaxic Instrument
- PDQNeurosurgical Nerve Locator
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- DTEPulse-Generator, Pacemaker, External
- FDGRetractor, Fiberoptic
- LHISet, I.V. Fluid Transfer
- PLRSpinal Vertebral Body Replacement Device - Cervical
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- GWFStimulator, Electrical, Evoked Response
- IPFStimulator, Muscle, Powered
- NGXStimulator, Muscle, Powered, For Muscle Conditioning
- ETNStimulator, Nerve
- LLZSystem, Image Processing, Radiological
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- IZHSystem, X-Ray, Mammographic
- FQOTable, Operating-Room, Ac-Powered
- KGXTape And Bandage, Adhesive
- DTATester, Pacemaker Electrode Function
- NKBThoracolumbosacral Pedicle Screw System
- KNTTubes, Gastrointestinal (And Accessories)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0487-2024 | Remington MEDICAL Drainage Bag, REF 600-D; | There is an error with the "Use by Date" and "Date of Manufacturer" on the box label. | Class II | Open, Classified | |
| Z-0771-2023 | Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1) | The stylet is longer than specified on the label | Class II | Terminated | |
| Z-1441-2014 | FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. Electrical extension cable intended to transmit signal from, or power or excitation signal to patient connected electrodes. The cable is a sterile, disposable device. | Remington Medical discovered an error on the FL-601-97 IFU; part number IFU-RM-0154. Specifically, the polarity for the black chuck in the picture is wrong. It shows (+), but should show (-). | Class II | Terminated | |
| Z-0028-2013 | Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilitate depth placement. | Sterility of the product may be compromised. | Class II | Terminated | |
| Z-1577-2011 | Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1825M, 18ga (1.3mm) x 25cm (10), Remington Medical, Inc. | There is a potential for the needle hubs to break during use. | Terminated | ||
| Z-1576-2011 | Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1820M, 18ga (1.3mm) x 20cm (10), Remington Medical, Inc. | There is a potential for the needle hubs to break during use. | Terminated | ||
| Z-1575-2011 | Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1825MLL, 18ga (1.3mm) x 25cm (10), Remington Medical, Inc. | There is a potential for the needle hubs to break during use. | Terminated | ||
| Z-1574-2011 | Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1820MLL, 18ga (1.3mm) x 20cm (10), Remington Medical, Inc. | There is a potential for the needle hubs to break during use. | Terminated | ||
| Z-1573-2011 | Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-14010MLL, 14ga (2.1mm) x 10cm (10), Remington Medical, Inc. | There is a potential for the needle hubs to break during use. | Terminated | ||
| Z-2405-2011 | Drainage Bag, Model 600D, 600 mL, Single use, Ethylene Oxide sterilized, Remington Medical, Inc., 6830 Meadowridge Court, Alpharetta, GA 30005. The Biliary Drainage Bag is used to aid with fluid drainage involving abscess, biliary and nephrostomy. Mechanical failure of this device would result in patient discomfort. This device is not life sustaining no life supporting. The medical device is not intended to be implanted. This medical device has surface contact with the patient. Improper use of this device could cause fluid back-up and result in invasive contact through the catheter. The drainage bag will be used in conjunction with a nephrostomy/biliary drainage catheter. | There have been complaints of the Drainage Bags leaking from the outlet and the inlet port. | Terminated | ||
| Z-2223-2010 | Disposable Surgical Cable, Product Code: FL-601-97 (100), Single use, Rx Only, Remington Medical, Inc., 6830 Meadowridge Court, Alpharetta, GA 30005 Usage: Temporary pacing of open hearts: used with External Pacing Generators (EPGs). | The Safe Connect component may separate from the cable, causing the cable to become unplugged from the EPG. | Terminated | ||
| Z-1935-2009 | Chiba Needle Marked Model: CNM-2308, Size: 23 GA x 20 CM, Remington Medical, Inc., Alpharetta, GA 30005. General purpose aspiration Cytology Biopsy Needle | Two unsealed pouches were identified after product release, compromising product sterility. | Terminated | ||
| Z-1417-2009 | CHIBA NEEDLE MARKED, Model CNM-1806, Size: 18 GA x 15 CM, Qty: 10 each, Remington Medical, Inc., Alpharetta, GA 30005. The device is used as a General Purpose Aspiration and Injection Needle. | Incorrect needle (Franseen Needle, FNM-1806) was packaged as a Chiba Needle Marked. | Terminated | ||
| Z-0058-2008 | Remington Medical, Inc, (RMI) -- Urinary Drainage Bags: 500ml Disposable Urinary Leg Bag (Order number: 500-D) and 1000ml Disposible Urinary Leg Bag (Order number 1000-D) -- Sterile Fluid Path, For Single Use Only, Remington Medical, Inc., Alpharetta, GA 30005. | Sterility, inadequate -- Pathway may not be sterile as labeled. | Terminated | ||
| Z-0673-2007 | Prostate Biopsy Needle, Model: NAC-1825BB, Soxe 18 GA x 25 CM, Single use, Ethylene sterilized, Non-pyrogenic, Remington Medical, Inc., Alpharetta, GA 30005. | Pouches were not sealed prior to sterilization. | Terminated | ||
| Z-0124-06 | Model 6149 Pacing Vector Selector Cable Switch for use with Pacing System Analyzers * Rx only * Contents Are Not Sterile * Manufactured by Remington Medical Incorporated, 6830 Meadowridge Court, Alpharetta, GA 30005, (770) 888-8520 or (800) 999-0057 * Distributed By: Guidant Corporation, 4100 Hamine Avenue North, St. Paul, MN 55112-5798 USA. | The vector selector has an electrical design flaw which prevents RV pacing. | Terminated | ||
| Z-0067-06 | Remington Medical, Inc., 8 French-Sheath Only, Size 8 French, Single Use. Ethylene Oxide sterilized. | The Tear-Away introducer sheath in the Disposable Tear-Away Vascular Introducer kits may exhibit cracked hubs/handles and/or improper peeling of the sheath during use. | Terminated | ||
| Z-0066-06 | Remington Medical, Inc. Ten Disposable Tear-Away Introducer Sets, Size 8 French, Sterile: Single Use/Disposable Radiopague Contents Ethylene Oxide Sterilized | The Tear-Away introducer sheath in the Disposable Tear-Away Vascular Introducer kits may exhibit cracked hubs/handles and/or improper peeling of the sheath during use. | Terminated | ||
| Z-0065-06 | Remington Medical, Inc. Ten Disposable Tear-Away Introducer Sets Size 7 French, Sterile: Single Use/Disposable Radiopaque Contents Ethylene Oxide Sterilized. | The Tear-Away introducer sheath in the Disposable Tear-Away Vascular Introducer kits may exhibit cracked hubs/handles and/or improper peeling of the sheath during use. | Terminated | ||
| Z-0697-05 | Automatic Cutting Needle, Model: NAC-1820B, Size 18 GA x 20 CM, Lot: xxxx, Single Use: Ethylene Oxide sterilized. Remington Medical, Inc., Alpharetta, GA 30005. | The stylet hub detaches from the stylet needle. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain