Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014840003

FEI Number

3014840003

Entity Name

Fetzer Medical Hungaria KFT.

City/State/Country

Hosszupalyi Hajdu-Bihar, HU

Establishment Address

Bartok Bela u 1, Hosszupalyi Hajdu-Bihar 4274, HU

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

KAL-DOB 2001 Ipari es Kereskedelmi Korlatolt Felelossegu Tar (Owner Number: 10058379)

Owner / Operator Contact Address

Bartok Bela u 1, Hosszupalyi, HU-HB 4274, HU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Scissors, General, Surgical Retractor Suction Irrigator Irrigator, Sinus Cannula, Surgical, General & Plastic Surgery Instrument, Ligature Passing and Knot Tying Ligature Carrier Clamp

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2018-09-07
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2018-09-07
KAR	Irrigator, Sinus	Ear, Nose, Throat	Class 1	874.4420	2018-09-07
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2018-09-07
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2018-09-07
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2018-09-07

Official Correspondent

Daniela Nann

US Agent Details

Max Fetzer Business: Fetzer Surgical LLC. Email: max@fetzersurgical.com Phone: (602) 8057005

Related Public Records

Same Entity

KAL-DOB 2001 Ipari es Kereskedelmi Korlatolt Felelossegu Tar

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
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09

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

Registration Number	Establishment Name	Location
8010298	RUDOLF MEDICAL GMBH + CO. KG	FRIDINGEN Baden-Wurttemberg, DE
8043496	REDA INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE
8040373	NADEEM SURGICAL CORP. PRIVATE LTD.	SIALKOT Punjab, PK
2531475	URAMIX, INC.	E Lansdowne, PA, US
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014840003. Last updated year: 2026. Please use registration number 3014840003 when referencing this establishment in official correspondence.