Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2245574

FEI Number

2245574

Entity Name

NIKOMED U.S.A., INC.

City/State/Country

Hatboro, PA, US

Establishment Address

2800 Turnpike Dr, Hatboro, PA 19040, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

NIKOMED U.S.A., INC. (Owner Number: 9023845)

Owner / Operator Contact Address

2800 Turnpike Drive, Hatboro, PA 19040, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K102173

PMA Number

N/A

All Registered Proprietary Names

NIKOClips NIKOTABS NIKOPrep NIKOTRACE NIKOSURG NIKO-Surg TRACE1 NIKO THERMAL REFLECTORS Paco-flow orthopedic suction tip Gallant Disposable Prep Razor ME Medical Surgical Clipper MESI BP Cuffs NIKO-Surg Nikomed ECG Cable Coreshieldz Disposable Non-Surgical Gown NIKO-Surg CPR Mask Vivolight MESI ABPI MD MESI mTABLET ABI Moldex

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2018-03-14
HAM	Apparatus, Electrosurgical	General, Plastic Surgery	Class 2	878.4400	2026-04-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-04-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-12-04
HAM	Apparatus, Electrosurgical	General, Plastic Surgery	Class 2	878.4400	2019-12-04
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2010-01-05
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2025-12-09
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2023-03-27
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	2018-06-26
JOM	Plethysmograph, Photoelectric, Pneumatic Or Hydraulic	Cardiovascular	Class 2	870.2780	2019-04-04
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2019-03-19
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2014-12-31
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-06-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2010-01-05
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2019-03-18
KZA	Device, Vein Location, Liquid Crystal	General Hospital	Class 1	880.6970	2019-06-18
JOM	Plethysmograph, Photoelectric, Pneumatic Or Hydraulic	Cardiovascular	Class 2	870.2780	2019-04-04
JOM	Plethysmograph, Photoelectric, Pneumatic Or Hydraulic	Cardiovascular	Class 2	870.2780	2021-06-28
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-02-24

Official Correspondent

STEPHEN EPSTEIN

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NIKOMED U.S.A., INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K934333	3M Medical Products Group	3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE	1994-07-07
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

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3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3017425211	LOHMANN PRECISION DIE CUTTING, LLC	Orange, VA, US
3008773647	CARDIONET, LLC	Phoenix, AZ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2245574. Last updated year: 2026. Please use registration number 2245574 when referencing this establishment in official correspondence.