Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005977121

FEI Number

3005977121

Entity Name

BihlerMed, LLC

City/State/Country

Phillipsburg, NJ, US

Establishment Address

85 INDUSTRIAL DRIVE, Phillipsburg, NJ 08865, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BihlerMed, LLC (Owner Number: 9092868)

Owner / Operator Contact Address

85 Industrial Drive, Phillipsburg, NJ 08865, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SafeBreak Vascular Scintillant Retractor SCINTILLANT LIGHT Chemo Mouthpiece Scintillant Surgical Light Scintillant Dual Tip Surgical Light SurgiLight

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QOI	Intravenous Catheter Force-Activated Separation Device.	General Hospital	Class 2	880.5220	2022-08-04
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2007-01-17
QUA	Intraoral Cooling Device	Dental	Class 2	872.5590	2024-03-18
FTD	Lamp, Surgical	General, Plastic Surgery	Class 2	878.4580	2008-06-20
FTD	Lamp, Surgical	General, Plastic Surgery	Class 2	878.4580	2015-04-29
FTD	Lamp, Surgical	General, Plastic Surgery	Class 2	878.4580	2019-06-28

Official Correspondent

Eric Tarnowski

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BihlerMed, LLC

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
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

Similar Registrations

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3023851856	Border Assembly S de RL de CV	TIJUANA Baja California, MX
3017705285	LINEAR HEALTH SCIENCES LLC	Norman, OK, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005977121. Last updated year: 2026. Please use registration number 3005977121 when referencing this establishment in official correspondence.