Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2432320

FEI Number

1000521377

Entity Name

NOVAMED-USA

City/State/Country

Elmsford, NY, US

Establishment Address

4 WESTCHESTER PLZ STE 137, Elmsford, NY 10523, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

NovaMedUSA, Inc (Owner Number: 10030147)

Owner / Operator Contact Address

4 Westchester Plaza, Elmsford, NY 10523, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K063477

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2011-04-21
KRI	Accessory Equipment, Cardiopulmonary Bypass	Cardiovascular	Class 1	870.4200	2013-05-13
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2011-04-20
BZT	Stethoscope, Esophageal, With Electrical Conductors	Anesthesiology	Class 2	868.1920	2009-08-19
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2014-05-23
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2009-08-19

Official Correspondent

Peter Derrico

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NovaMedUSA, 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
K171373	3M Company	3M Bair Hugger Model 675 Total Temperature Management System	2017-10-10
K083336	Smiths Medical Asd, Inc.	LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL	2009-06-03
K233013	Silq Technologies Corporation	2-Way 100% Silicone Cleartract Catheter	2024-01-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2010	Cincinnati Sub-Zero Products Inc	2	WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming patients before, during and after surgery, and other specialty procedures.
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only

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9680284	3M EDUMEX, S.A DE C.V	CD. JUAREZ Chihuahua, MX
3012307300	ICU Medical, Inc.	Minneapolis, MN, US
1060680	DeRoyal Industries, Inc.	NEW TAZEWELL, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2432320. Last updated year: 2026. Please use registration number 2432320 when referencing this establishment in official correspondence.