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Data / Medical devices / United States / Remington Medical, Inc.

Remington Medical, Inc.: FDA-registered device maker in Alpharetta, GA, United States, 11 510(k) clearances

Remington Medical, Inc. is registered with the FDA (registration 1056553) in Alpharetta, GA, United States. It lists 43 device types. The FDA files 11 510(k) clearances under its listings, the newest dated November 20, 2025. 14 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Remington Medical, Inc.
FDA registration number
1056553
FEI number
1000132370
Address
6830 Meadowridge Ct, Alpharetta, GA, United States, 30005
Owner or operator
REMINGTON MEDICAL, INC. (9006473)
Roles
Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
First device listed
February 28, 2006
Registered through
2026
Brand names listed
10cc Locking Syringe, 301-CG Family, ADAP-1 Family, ADAP-2 Family, ADAP-2000 Family, ADAP-2R Family, ADAP-2RL Family, Adapter Cap and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal InterlaminalKWP2Contract manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Contract manufactureraccessdata.fda.gov
Bag, Bile CollectingEXF2Manufactureraccessdata.fda.gov
Bone Cement, Posterior Screw AugmentationPML2Contract manufactureraccessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)DSA2Contract manufacturer, Manufactureraccessdata.fda.gov
Catheter, SteerableDRA2Manufacturer for exportaccessdata.fda.gov
Cuff, Tracheal Tube, InflatableBSK2Contract manufactureraccessdata.fda.gov
Dispenser, Liquid MedicationKYX1Contract manufactureraccessdata.fda.gov
Electrode, CutaneousGXY2Contract manufactureraccessdata.fda.gov
Electrode, NeedleGXZ2Contract manufactureraccessdata.fda.gov
Electromyograph, DiagnosticIKN2Contract manufactureraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Contract manufactureraccessdata.fda.gov
Filler, Bone Void, Calcium CompoundMQV2Contract manufactureraccessdata.fda.gov
Flowmeter, Blood, CardiovascularDPW2Manufactureraccessdata.fda.gov
Instrument, BiopsyKNW2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Instrument, Ultrasonic SurgicalLFLUContract manufactureraccessdata.fda.gov
Instruments, Surgical, CardiovascularDWS1Manufactureraccessdata.fda.gov
Interventional Fluoroscopic X-Ray SystemOWB2Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, ThoracicPHM2Contract manufactureraccessdata.fda.gov
Introducer, CatheterDYB2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Light, Surgical, FiberopticFST2Contract manufactureraccessdata.fda.gov
Marker, SkinFZZ1Contract manufactureraccessdata.fda.gov
Needle, Aspiration And Injection, DisposableGAA1Repackager or relabeler, Specification developeraccessdata.fda.gov
Needle, Tumor LocalizationMIJ1Repackager or relabeleraccessdata.fda.gov
Neurological Stereotaxic InstrumentHAW2Contract manufactureraccessdata.fda.gov
Neurosurgical Nerve LocatorPDQ2Contract manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Contract manufactureraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Contract manufactureraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Contract manufactureraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Contract manufactureraccessdata.fda.gov
Set, I.V. Fluid TransferLHI2Manufactureraccessdata.fda.gov
Spinal Vertebral Body Replacement Device - CervicalPLR2Contract manufactureraccessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesKCT2Contract manufactureraccessdata.fda.gov
Stimulator, Electrical, Evoked ResponseGWF2Contract manufactureraccessdata.fda.gov
Stimulator, NerveETN2Contract manufactureraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Contract manufactureraccessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-IntensifiedJAA2Contract manufactureraccessdata.fda.gov
System, X-Ray, MammographicIZH2Manufactureraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Contract manufactureraccessdata.fda.gov
Tester, Pacemaker Electrode FunctionDTA2Contract manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Contract manufactureraccessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)KNT2Contract manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 20, 2025K251904VascuChek 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)DPWSubstantially EquivalentRemington Medical, Inc.accessdata.fda.gov
January 27, 2022K211589VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek ChargerDPWSubstantially EquivalentRemington Medical, Inc.accessdata.fda.gov
October 7, 2021K212065VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek ChargerDPWSubstantially EquivalentRemington Medical, Inc.accessdata.fda.gov
July 12, 2019K191315Remington Medical, Inc. Automatic Cutting Needle (NAC)KNWSubstantially EquivalentRemington Medical, Inc.accessdata.fda.gov
August 12, 1999K990428DRAINAGE BAGEXFSubstantially EquivalentRemington Medical, Inc.accessdata.fda.gov
November 3, 1998K983621NEEDLE GUIDEIZHSubstantially EquivalentRemington Medical, Inc.accessdata.fda.gov
September 8, 1998K982401PROSTATE BIOPSY NEEDLEKNWSubstantially EquivalentRemington Medical, Inc.accessdata.fda.gov
August 26, 1997K972134BAG DECANTERLHISubstantially EquivalentRemington Medical, Inc.accessdata.fda.gov
July 23, 1997K971968SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97)DSASubstantially EquivalentRemington Medical, Inc.accessdata.fda.gov
September 29, 1994K943651TECHNA-CUT ASPIRATION NEEDLEKNWSubstantially EquivalentManan Medical Products, Inc.accessdata.fda.gov
November 9, 1993K932370REMINGTON MEDICAL DISPOS TEAR-AWAY VASC INTRO SETDYBSubstantially EquivalentRemington Medical, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
November 3, 202393377Class IIOngoingRemington MEDICAL Drainage Bag, REF 600-DThere is an error with the "Use by Date" and "Date of Manufacturer" on the box label.accessdata.fda.gov
December 2, 202291275Class IITerminatedRemington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)The stylet is longer than specified on the labelaccessdata.fda.gov
March 5, 201467752Class IITerminatedFAS-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, 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 (-).accessdata.fda.gov
August 29, 201263070Class IITerminatedAutomatic 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 UrSterility of the product may be compromised.accessdata.fda.gov
February 7, 201157885Not yet classifiedTerminatedAutomatic 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.accessdata.fda.gov
January 12, 201158664Not yet classifiedTerminatedDrainage 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 abscesThere have been complaints of the Drainage Bags leaking from the outlet and the inlet port.accessdata.fda.gov
May 19, 201055804Not yet classifiedTerminatedDisposable 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 GenerThe Safe Connect component may separate from the cable, causing the cable to become unplugged from the EPG.accessdata.fda.gov
June 19, 200952781Not yet classifiedTerminatedChiba Needle Marked Model: CNM-2308, Size: 23 GA x 20 CM, Remington Medical, Inc., Alpharetta, GA 30005. General purpose aspiration Cytology Biopsy NeedleTwo unsealed pouches were identified after product release, compromising product sterility.accessdata.fda.gov
April 6, 200951962Not yet classifiedTerminatedCHIBA 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.accessdata.fda.gov
July 23, 200744938Not yet classifiedTerminatedRemington 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, ReminSterility, inadequate -- Pathway may not be sterile as labeled.accessdata.fda.gov
January 19, 200737600Not yet classifiedTerminatedProstate 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.accessdata.fda.gov
August 31, 200533490Not yet classifiedTerminatedModel 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, or The vector selector has an electrical design flaw which prevents RV pacing.accessdata.fda.gov
June 6, 200532667Not yet classifiedTerminatedRemington 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.accessdata.fda.gov
February 15, 200531527Not yet classifiedTerminatedAutomatic 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.accessdata.fda.gov

Compare with other makers

Updated November 20, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.