Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680424

FEI Number

3002806512

Entity Name

BAERAMED INSTRUMENTE GMBH

City/State/Country

SCHWENNINGEN Baden-Wurttemberg, DE

Establishment Address

ENZIANSTRASSE 1, SCHWENNINGEN Baden-Wurttemberg 72477, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BAERAMED INSTRUMENTE (Owner Number: 9008940)

Owner / Operator Contact Address

ENZIANSTRASSE 1, --, SCHWENNINGEN, DE-NOTA D-72477, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Gynex Corporation WA 98073 Redmond

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2012-09-10
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2012-09-10
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2012-09-10
HHF	Remover, Intrauterine Device, Contraceptive, Hook-Type	Obstetrics/Gynecology	Class 1	884.4530	2014-03-12
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2012-09-10
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2012-09-10
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2020-09-07
HTX	Rongeur	Orthopedic	Class 1	888.4540	2012-09-10
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	1994-04-20
HAB	Saw, Powered, And Accessories	General, Plastic Surgery	Class 1	878.4820	2012-09-10
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2010-01-22
KBB	Rongeur, Nasal	Ear, Nose, Throat	Class 1	874.4420	2012-09-10
GWY	Pinwheel	Neurology	Class 1	882.1750	2012-09-10
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2012-09-10
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2012-09-10
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2012-09-10
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-09-10
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2012-09-10
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2012-09-10
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2012-09-10
KDG	Chisel (Osteotome)	General, Plastic Surgery	Class 1	878.4820	2012-09-10
LGH	Instrument, Cast Removal, Ac-Powered	Orthopedic	Class 1	888.5960	2012-09-10

Official Correspondent

No official correspondent registered.

US Agent Details

Beate Weiss-Krull Business: Beate Weiss-Krull, Attorney at Law Email: bea@weisskrull-law.com Phone: (503) 2340355

Related Public Records

Same Entity

BAERAMED INSTRUMENTE

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
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-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.

Similar Registrations

Registration Number	Establishment Name	Location
9617426	PFAU MEDIZINISCHE INSTRUMENTE GMBH	WANFRIED Hesse, DE
3004530184	ANDERSEN CALEDONIA LTD	Bellshill Scotland, GB
3013358456	EMPIRE SURGICAL INSTRUMENTS COMPANY	Sialkot Punjab, PK
8043507	EISENHUT INSTRUMENTE GMBH	FRITTLINGEN Baden-Wurttemberg, DE
1123010	TRINITY STERILE, INC.	SALISBURY, MD, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680424. Last updated year: 2026. Please use registration number 9680424 when referencing this establishment in official correspondence.