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REMINGTON MEDICAL, INC.

United States·US-MF-000002612

Last updated September 17, 2026

What REMINGTON MEDICAL, INC. makes

Remington Medical, Inc. manufactures single-use needles for medical procedures, including body aspiration, epidural insertion, prostate and bone marrow biopsy, and intra-arterial access. Their portfolio also includes vascular catheter introduction sets and general-purpose syringes. Additionally, they produce diagnostic tools like laser Doppler blood flowmeters, which measure blood flow in tissues.

The company’s devices are regulated under FDA Class I and Class II (including Class IIa) classifications and are listed in the EUDAMED database, FDA’s 510(k) premarket notifications, and FDA’s Unique Device Identifier (UDI) registry. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Remington Medical, Inc. manufacture?

Remington Medical, Inc. specializes in single-use medical devices primarily focused on needles and related tools. Their portfolio includes body aspiration needles, epidural needles (non-threaded), prostate and bone marrow biopsy needles, intra-arterial needles, and general-purpose syringes. They also produce vascular catheter introduction sets and diagnostic tools like laser Doppler blood flowmeters, which assess tissue blood flow. These devices are designed for procedures requiring precision access or measurement.

Where is Remington Medical, Inc. based, and how does that affect its regulatory standing?

Remington Medical, Inc. is based in the United States. Since the company operates under U.S. regulatory oversight, its devices are evaluated and listed in the FDA’s systems, including the 510(k) premarket notification database and the Unique Device Identifier (UDI) registry. This means their products must comply with FDA requirements for classification (Class I or Class II/IIa) and are tracked accordingly. The EUDAMED database also lists their devices, indicating they are marketed in the European Economic Area.

Which regulatory registries list Remington Medical, Inc.’s devices?

Remington Medical, Inc.’s devices are listed in multiple global regulatory registries to ensure transparency and compliance. They appear in EUDAMED, the European database for medical devices, as well as the FDA’s 510(k) premarket notifications and FDA’s UDI registry, which catalogs U.S.-authorized devices by their unique identifiers. These listings reflect their distribution in both the U.S. and the European Economic Area.

How are Remington Medical, Inc.’s devices classified under U.S. and EU regulations?

Remington Medical, Inc.’s devices fall under FDA Class I (low-risk, generally exempt from premarket review) or Class II/IIa (moderate-risk, requiring special controls or premarket submissions). Class II/IIa devices often include needles and biopsy tools due to their procedural risks, while Class I may cover simpler single-use items like general-purpose syringes. In the EU, these classifications align with MDD/IVDR risk categories, though exact EU classification isn’t specified here. The company’s devices are authorized separately in each market based on their specific risks.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 6830, Meadowridge Court, Alpharetta, United States
Website: remmed.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)989-0057
PRRC Contact: Dorothy Frieser
EUDAMED SRN: US-MF-000002612
FDA FEI Number: 1000132370
DUNS Number: 788472314

Catalogue (224)

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Device	Model / Reference	Registries	Class	Status
VascuChek Kit	VC-KIT-01	FDA UDI	Class II	Active
Franseen Needle Marked	FNM-2003	FDA UDI	Class I	Active
Automatic Cutting Needle	NAC-1820U	FDA UDI	Class II	Active
Bone Marrow "J" Needle with Double Diamond Tip	JD-1106-NS	FDA UDI	Class I	Active
Tuohy Epidural Needle	TNMF-1703NS	FDA UDI	Class II	Active
Chiba Needle Marked	CNM-1806NS	FDA UDI	Class I	Active
Tuohy Epidural Needle	TNMR-1902	FDA UDI	Class II	Active
Tuohy Epidural Needle	TNMR-1703NS	FDA UDI	Class II	Active
Breast Needle Locator	BNL-2005	FDA UDI	Class I	Active
Luer Loc Standard Syringe	LLS-10-W	FDA UDI	Class II	Active
Automatic Cutting Needle	NAC-1825U	FDA UDI	Class II	Active
Chiba Needle Marked	CNM-2306	FDA UDI	Class I	Active
Automatic Cutting Needle	NAC-1825MLL	FDA UDI	Class II	Active
Tuohy Epidural Needle	TNMF-2006	FDA UDI	Class II	Active
Automatic Cutting Needle	NAC-1816BB	FDA UDI	Class II	Active
Guidewire Introducer Needle Winged Base Plate	BGWI-1802	FDA UDI	Class I	Active
Tuohy Epidural Needle	TNMF-1705	FDA UDI	Class II	Active
Westcott Needle Marked	WNM-2006	FDA UDI	Class I	Active
Guidewire Introducer Needle Square Hub Access Needle	GWI-1902WW	FDA UDI	Class I	Active
Franseen Needle Marked	FNM-2008	FDA UDI	Class I	Active
Bone Marrow "J" Needle Double Diamond Tip	JD-1104	FDA UDI	Class I	Active
Open Needle Guide	LNGO-2022	FDA UDI	Class II	Active
Automatic Cutting Needle	NAC-1820 ULTRA	FDA UDI	Class II	Active
Franseen Needle Marked	FNM-2206	FDA UDI	Class I	Active
Bag Decanter	9002	FDA UDI	Class II	Active
Chiba Needle Marked	CNM-2008	FDA UDI	Class I	Active
Automatic Cutting Needle	NAC-1816	FDA UDI	Class II	Active
Guidewire Introducer Needle Winged Base Plate	BGWI-1902	FDA UDI	Class I	Active
Automatic Cutting Needle	NAC-1410MLL	FDA UDI	Class II	Active
Safety Adapter	ADAP-2RL	FDA UDI	Class II	Active
Closed Needle Guide	LNGC-14	FDA UDI	Class II	Active
Tuohy Epidural Needle	TNMF-2203NS	FDA UDI	Class II	Active
Chiba Needle Marked	CNM-2306NS	FDA UDI	Class I	Active
VascuChek Surgical Probe	VC-SP-01	FDA UDI	Class II	Active
Luer Loc Standard Syringe	LLS-10-B	FDA UDI	Class II	Active
Chiba Needle Marked	CNM-1808	FDA UDI	Class I	Active
Tuohy Epidural Needle	TNMF-1902	FDA UDI	Class II	Active
Guidewire Introducer Needle Guidewire Access Needle	GWI-1802-NS	FDA UDI	Class I	Active
Tuohy Epidural Needle	TNMR-1805	FDA UDI	Class II	Active
Tuohy Epidural Needle	TNMF-1803NS	FDA UDI	Class II	Active
Automatic Cutting Needle	NAC-1825 ULTRA	FDA UDI	Class II	Active
Necessities Kit	NK-01	FDA UDI	Class II	Active
Automatic Cutting Needle	NAC-1825BB	FDA UDI	Class II	Active
Disposable Tear-Away Vascular Introducer Set	7007	FDA UDI	Class II	Active
Westcott Needle Marked	WNM-2006NS	FDA UDI	Class I	Active
Automatic Cutting Needle	NAC-1816B	FDA UDI	Class II	Active
Chiba Needle Marked	CNM-1803	FDA UDI	Class I	Active
Automatic Cutting Needle	NAC-1820MLL	FDA UDI	Class II	Active
Chiba Needle Marked	CNM-2207	FDA UDI	Class I	Active
Disposable Tear-Away Vascular Introducer Set	7010	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (20)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Remington Medical, Inc. has 20 recall records spanning from February 15, 2005, to November 3, 2023, with statuses recorded as open, classified, or terminated. The reasons cited include issues such as leakage in drainage bags, potential needle hub breakage, mislabeling of use-by dates and manufacturer dates, incorrect needle packaging, compromised sterility, improper sealing of pouches, incorrect polarity instructions, cable disconnection risks, incorrect stylet length labeling, cracked or improperly peeled sheaths in introducer kits, and an electrical design flaw in vector selectors.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Nov 3, 2023	Z-0487-2024	—	open, classified	There is an error with the "Use by Date" and "Date of Manufacturer" on the box label.
Dec 2, 2022	Z-0771-2023	—	terminated	The stylet is longer than specified on the label
Mar 5, 2014	Z-1441-2014	—	terminated	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 (-).
Aug 29, 2012	Z-0028-2013	—	terminated	Sterility of the product may be compromised.
Feb 7, 2011	Z-1575-2011	—	terminated	There is a potential for the needle hubs to break during use.
Feb 7, 2011	Z-1573-2011	—	terminated	There is a potential for the needle hubs to break during use.
Feb 7, 2011	Z-1576-2011	—	terminated	There is a potential for the needle hubs to break during use.
Feb 7, 2011	Z-1577-2011	—	terminated	There is a potential for the needle hubs to break during use.
Feb 7, 2011	Z-1574-2011	—	terminated	There is a potential for the needle hubs to break during use.
Jan 12, 2011	Z-2405-2011	—	terminated	There have been complaints of the Drainage Bags leaking from the outlet and the inlet port.
May 19, 2010	Z-2223-2010	—	terminated	The Safe Connect component may separate from the cable, causing the cable to become unplugged from the EPG.
Jun 19, 2009	Z-1935-2009	—	terminated	Two unsealed pouches were identified after product release, compromising product sterility.
Apr 6, 2009	Z-1417-2009	—	terminated	Incorrect needle (Franseen Needle, FNM-1806) was packaged as a Chiba Needle Marked.
Jul 23, 2007	Z-0058-2008	—	terminated	Sterility, inadequate -- Pathway may not be sterile as labeled.
Jan 19, 2007	Z-0673-2007	—	terminated	Pouches were not sealed prior to sterilization.
Aug 31, 2005	Z-0124-06	—	terminated	The vector selector has an electrical design flaw which prevents RV pacing.
Jun 6, 2005	Z-0067-06	—	terminated	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.
Jun 6, 2005	Z-0066-06	—	terminated	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.
Jun 6, 2005	Z-0065-06	—	terminated	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.
Feb 15, 2005	Z-0697-05	—	terminated	The stylet hub detaches from the stylet needle.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Remington Medical Markham Ontario · CA FEI 3001676837