Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617426

FEI Number

3002935209

Entity Name

PFAU MEDIZINISCHE INSTRUMENTE GMBH

City/State/Country

WANFRIED Hesse, DE

Establishment Address

DROSSELWEG 7, WANFRIED Hesse 37281, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PFAU MEDIZINISCHE INSTRUMENTE GMBH (Owner Number: 9035248)

Owner / Operator Contact Address

DROSSELWEG 7, --, WANFRIED, DE-HE 37281, 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
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2007-11-23
JYO	Knife, Ear	Ear, Nose, Throat	Class 1	874.4420	2007-11-23
KBP	Hook, Tonsil Suturing	Ear, Nose, Throat	Class 1	874.4420	2009-01-12
KAD	Elevator, Ent	Ear, Nose, Throat	Class 1	874.4420	2007-11-23
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2013-02-02
HXG	Tamp	Orthopedic	Class 1	888.4540	2001-04-02
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2007-11-23
JZY	Knife, Laryngeal	Ear, Nose, Throat	Class 1	874.4420	2009-01-12
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2001-10-18
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2008-01-18
KAI	Mirror, Ent	Ear, Nose, Throat	Class 1	874.4420	2009-01-12
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2001-04-02
KTF	Punch, Ent	Ear, Nose, Throat	Class 1	874.4420	2007-11-23
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-08-30
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2000-03-07
KBA	Rasp, Nasal	Ear, Nose, Throat	Class 1	874.4420	2009-01-12
JZB	Scissors, Ear	Ear, Nose, Throat	Class 1	874.4420	2007-11-23
JYY	Rasp, Ear	Ear, Nose, Throat	Class 1	874.4420	2007-11-23
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2018-06-11
NNR	Block, Cutting, Ent, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2007-11-23
KAS	Knife, Nasal	Ear, Nose, Throat	Class 1	874.4420	2009-01-12
JYE	Chisel, Middle-Ear	Ear, Nose, Throat	Class 1	874.4420	2007-11-23
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2019-10-22
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2007-11-23
NNS	Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2007-11-23
JYQ	Loop, Wire	Ear, Nose, Throat	Class 1	874.4420	2009-01-12
KBD	Scissors, Nasal	Ear, Nose, Throat	Class 1	874.4420	2009-01-12
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2011-03-17
JYJ	Gauge, Measuring	Ear, Nose, Throat	Class 1	874.4420	2007-11-23
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2009-01-12
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	2007-12-28
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2014-08-15

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

PFAU MEDIZINISCHE 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
K914226	E.I. Dupont DE Nemours & Co., Inc.	ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK	1991-11-19

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.
Z-0040-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0041-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0042-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0043-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 6mm Offset (Green) Catalog Number: 72201716 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

Similar Registrations

Registration Number	Establishment Name	Location
9680424	BAERAMED INSTRUMENTE GMBH	SCHWENNINGEN Baden-Wurttemberg, 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 9617426. Last updated year: 2026. Please use registration number 9617426 when referencing this establishment in official correspondence.