Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010733

FEI Number

3001417518

Entity Name

PRO-MED INSTRUMENTE GMBH

City/State/Country

TUTTLINGEN Baden-Wurttemberg, DE

Establishment Address

9 GAENSAECKER, TUTTLINGEN Baden-Wurttemberg 78532, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PRO-MED Instrumente GmbH (Owner Number: 8010733)

Owner / Operator Contact Address

9 Gaensaecker, --, Tuttlingen, DE-NOTA 78532, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

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
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	1995-08-11
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	1995-08-11
KBW	Screw, Oral	Ear, Nose, Throat	Class 1	874.4420	1995-08-11
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	1995-08-11
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	1995-08-11
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	Class 1	876.4730	2003-06-18
HXW	Bender	Orthopedic	Class 1	888.4540	1995-08-11
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2018-02-02
HTX	Rongeur	Orthopedic	Class 1	888.4540	1995-08-11
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	1995-08-11
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2018-02-02
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2023-01-09
KCB	Tube, Tonsil Suction	Ear, Nose, Throat	Class 1	874.4420	2023-01-09
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	1985-01-14
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	1995-08-11
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1995-08-11
HXB	Probe	Orthopedic	Class 1	888.4540	2018-02-02
KAD	Elevator, Ent	Ear, Nose, Throat	Class 1	874.4420	1995-08-11
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2018-02-02
HTT	Burr, Orthopedic	Orthopedic	Class 1	888.4540	2018-02-02
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1985-01-14
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	1995-08-11

Official Correspondent

Jan Dinkelmann

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

PRO-MED Instrumente GmbH

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
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

Similar Registrations

Registration Number	Establishment Name	Location
9710524	ULTIMATE MEDICAL PRODUCTS LTD.	SHARJAH Ash Shariqah, AE
3003431869	HILBRO INTERNATIONAL (PVT) LIMITED	SIALKOT Punjab, PK
8010851	BERNHARD FREY	TUTTLINGEN Baden-Wurttemberg, DE
9611262	WILLY STORZ GMBH	Rietheim-Weilheim Baden-Wurttemberg, DE
9610773	OLYMPUS WINTER & IBE GMBH	HAMBURG, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010733. Last updated year: 2026. Please use registration number 8010733 when referencing this establishment in official correspondence.