Remington Medical, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 19
- Inspections
- 11
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0487-2024 | Class II | Remington MEDICAL Drainage Bag, REF 600-D; | November 3, 2023 |
| Z-0771-2023 | Class II | Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1) | December 2, 2022 |
| Z-1441-2014 | Class II | FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. Electrical extension cabl | March 5, 2014 |
| Z-0028-2013 | Class II | Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5 | August 29, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251904 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, V | November 20, 2025 |
| K241583 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX | August 30, 2024 |
| K211589 | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger | January 27, 2022 |
| K212065 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger | October 7, 2021 |
| K191315 | Remington Medical, Inc. Automatic Cutting Needle (NAC) | July 12, 2019 |
| K150266 | Remington Medical Inc. Tuohy Epidural Needles | June 4, 2015 |
| K130282 | REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT | May 13, 2013 |
| K050884 | ADAPTER CABLE | May 19, 2005 |
| K040266 | CORE NEEDLE BIOPSY | July 9, 2004 |
| K990428 | DRAINAGE BAG | August 12, 1999 |
| K983621 | NEEDLE GUIDE | November 3, 1998 |
| K982401 | PROSTATE BIOPSY NEEDLE | September 8, 1998 |
| K972134 | BAG DECANTER | August 26, 1997 |
| K971968 | SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97) | July 23, 1997 |
| K953812 | GAUZE SPONGE | October 2, 1995 |
| K946060 | REMINGTON MEDICAL DISPOSABLE FLUORO/EQUIPMENT COVER MODEL RMI8 | April 27, 1995 |
| K940467 | REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-601 | November 1, 1994 |
| K932370 | REMINGTON MEDICAL DISPOS TEAR-AWAY VASC INTRO SET | November 9, 1993 |
| K922009 | DISPOSABLE SURGICAL EXTENSION CABLE MODEL S-101 | February 25, 1993 |