Company ยท US
Remington Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2025. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (1 in 12 months)
20recalls (0 in 12 months)
14recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KNW | Instrument, Biopsy | 13 |
| DPW | Flowmeter, Blood, Cardiovascular | 4 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 4 |
| EXF | Bag, Bile Collecting | 4 |
| GWG | Endoscope, Neurological | 3 |
| DTA | Tester, Pacemaker Electrode Function | 2 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 1 |
| DTE | Pulse-Generator, Pacemaker, External | 1 |
| DYB | Introducer, Catheter | 1 |
| GDM | Needle, Aspiration And Injection, Reusable | 1 |
| IZH | System, X-Ray, Mammographic | 1 |
| KHR | Absorber, Saliva, Paper | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 |
| LHI | Set, I.V. Fluid Transfer | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 20, 2025 | K251904 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, Remington Medical, Inc. | DPW |
| Aug 30, 2024 | K241583 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH Remington Medical, Inc. | DPW |
| Jan 27, 2022 | K211589 | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger Remington Medical, Inc. | DPW |
| Oct 7, 2021 | K212065 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger Remington Medical, Inc. | DPW |
| Jul 12, 2019 | K191315 | Remington Medical, Inc. Automatic Cutting Needle (NAC) Remington Medical, Inc. | KNW |
| Jun 4, 2015 | K150266 | Remington Medical Inc. Tuohy Epidural Needles Remington Medical, Inc. | BSP |
| May 13, 2013 | K130282 | REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT Remington Medical, Inc. | KNW |
| May 19, 2005 | K050884 | ADAPTER CABLE Remington Medical, Inc. | DTA |
| Jul 9, 2004 | K040266 | CORE NEEDLE BIOPSY Remington Medical, Inc. | KNW |
| Aug 12, 1999 | K990428 | DRAINAGE BAG Remington Medical, Inc. | EXF |
| Nov 3, 1998 | K983621 | NEEDLE GUIDE Remington Medical, Inc. | IZH |
| Sep 8, 1998 | K982401 | PROSTATE BIOPSY NEEDLE Remington Medical, Inc. | KNW |
| Aug 26, 1997 | K972134 | BAG DECANTER Remington Medical, Inc. | LHI |
| Jul 23, 1997 | K971968 | SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97) Remington Medical, Inc. | DSA |
| Oct 2, 1995 | K953812 | GAUZE SPONGE Remington Medical, Inc. | KHR |
| Apr 27, 1995 | K946060 | REMINGTON MEDICAL DISPOSABLE FLUORO/EQUIPMENT COVER MODEL RMI8 Remington Medical, Inc. | KKX |
| Nov 1, 1994 | K940467 | REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-601 Remington Medical, Inc. | DTE |
| Nov 9, 1993 | K932370 | REMINGTON MEDICAL DISPOS TEAR-AWAY VASC INTRO SET Remington Medical, Inc. | DYB |
| Feb 25, 1993 | K922009 | DISPOSABLE SURGICAL EXTENSION CABLE MODEL S-101 Remington Medical, Inc. | DSA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 5, 2023 | Remington Medical, Inc. Remington MEDICAL Drainage Bag, REF 600-D; Open, Classified |
EXF | K990428 |
| Dec 28, 2022 | Remington Medical, Inc. Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1) Terminated |
KNW | K191315 |
| Apr 9, 2014 | Remington Medical Inc. 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 Terminated |
DSA | K971968 |
| Oct 9, 2012 | Remington Medical Inc. 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 a Terminated |
KNW | K982401 |
| Jun 2, 2011 | Remington Medical Inc. 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 dra Terminated |
EXF | None listed |
| Mar 7, 2011 | Remington Medical Inc. Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1825M, 18ga (1.3mm) x 25cm (10), Remington Medical, Inc. Terminated |
KNW | K040266 |
| Mar 7, 2011 | Remington Medical Inc. Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1820M, 18ga (1.3mm) x 20cm (10), Remington Medical, Inc. Terminated |
KNW | K040266 |
| Mar 7, 2011 | Remington Medical Inc. Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1825MLL, 18ga (1.3mm) x 25cm (10), Remington Medical, Inc. Terminated |
KNW | K040266 |
| Mar 7, 2011 | Remington Medical Inc. Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1820MLL, 18ga (1.3mm) x 20cm (10), Remington Medical, Inc. Terminated |
KNW | K040266 |
| Mar 7, 2011 | Remington Medical Inc. Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-14010MLL, 14ga (2.1mm) x 10cm (10), Remington Medical, Inc. Terminated |
KNW | K040266 |
| Aug 13, 2010 | Remington Medical Inc. 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 Terminated |
DSA | K971968 |
| Sep 20, 2009 | Remington Medical Inc. Chiba Needle Marked Model: CNM-2308, Size: 23 GA x 20 CM, Remington Medical, Inc., Alpharetta, GA 30005.
General purpose aspiration Cytology Biopsy Needle Terminated |
None listed | |
| May 26, 2009 | Remington Medical Inc. 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. Terminated |
GDM | None listed |
| Oct 23, 2007 | Remington Medical Inc. 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 S Terminated |
EXF | K990428 |
| Mar 29, 2007 | Remington Medical Inc. Prostate Biopsy Needle, Model: NAC-1825BB, Soxe 18 GA x 25 CM, Single use, Ethylene sterilized, Non-pyrogenic, Remington Medical, Inc., Alpharetta, GA 30005. Terminated |
KNW | K982401 |
| Nov 3, 2005 | Remington Medical Inc. 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, Alpha Terminated |
DTA | K050884 |
| Oct 21, 2005 | Remington Medical Inc. Remington Medical, Inc., 8 French-Sheath Only, Size 8 French, Single Use. Ethylene Oxide sterilized. Terminated |
GWG | None listed |
| Oct 21, 2005 | Remington Medical Inc. Remington Medical, Inc. Ten Disposable Tear-Away Introducer Sets, Size 8 French, Sterile: Single Use/Disposable Radiopague Contents Ethylene Oxide Sterilized Terminated |
GWG | None listed |
| Oct 21, 2005 | Remington Medical Inc. Remington Medical, Inc. Ten Disposable Tear-Away Introducer Sets Size 7 French, Sterile: Single Use/Disposable Radiopaque Contents Ethylene Oxide Sterilized. Terminated |
GWG | None listed |
| Apr 8, 2005 | Remington Medical Inc. 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. Terminated |
KNW | K982401 |