Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010422

FEI Number

3008238512

Entity Name

MAX HAUSER SUDDEUTSCHE CHIRURGIEMECHANIK GMBH

City/State/Country

TUTTLINGEN Baden-Wurttemberg, DE

Establishment Address

Im Mittleren Oesch 4, TUTTLINGEN Baden-Wurttemberg 78532, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MAX HAUSER SUDDEUTSCHE CHIRURGIEMECHANIK GMBH (Owner Number: 8010422)

Owner / Operator Contact Address

Im Mittleren Oesch 4, --, TUTTLINGEN, DE-BW 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
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2018-01-07
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2017-09-26
HTX	Rongeur	Orthopedic	Class 1	888.4540	1998-11-30
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2018-01-07
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2018-01-07
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1998-11-30
HGC	Clamp, Uterine	Obstetrics/Gynecology	Class 1	884.4520	2018-12-21
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2018-01-07
GEJ	Carrier, Ligature	General, Plastic Surgery	Class 1	878.4800	2018-04-12
FFN	Clamp, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2018-06-23
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	1992-10-15
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2018-01-07
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2019-09-25
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1998-11-30
EIG	Retractor, All Types	Dental	Class 1	872.4565	1992-10-07
HAE	Rongeur, Manual	Neurology	Class 2	882.4840	2010-04-01
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2018-04-12
KCG	Dilator, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2013-01-31
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2018-01-07
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2004-10-27
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2018-06-23
JYR	Nipper, Malleus	Ear, Nose, Throat	Class 1	874.4420	2018-02-17
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	2010-02-22
HDL	Retractor, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2012-09-28
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	1998-11-30
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1998-11-30
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2007-11-14
LGG	Instrument, Cast Application/Removal, Manual	Orthopedic	Class 1	888.5980	2013-11-21
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2009-09-04
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2018-05-28
FGN	Retractor, Non-Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	1998-11-30
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2010-03-18
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-05-20

Official Correspondent

No official correspondent registered.

US Agent Details

Angelika Scherp Business: BUSINESS SUPPORT INTERNATIONAL Email: info@bsi-fda.com Phone: (212) 3318358

Related Public Records

Same Entity

MAX HAUSER SUDDEUTSCHE CHIRURGIEMECHANIK 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
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010422. Last updated year: 2026. Please use registration number 8010422 when referencing this establishment in official correspondence.