Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9612278

FEI Number

3002806862

Entity Name

DUFNER INSTRUMENTE GMBH

City/State/Country

TUTTLINGEN Baden-Wurttemberg, DE

Establishment Address

FOEHRENSTR. 9, TUTTLINGEN Baden-Wurttemberg 78532, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DUFNER INSTRUMENTE GMBH (Owner Number: 8010266)

Owner / Operator Contact Address

FOEHRENSTR. 9, --, 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

PACKER, UTERINE KNIFE, SURGICAL FORCEPS, OPHTHALMIC FORCEPS, RONGEUR, SURGICAL SCOOP DURA HOOKS HOOKS TOP DUR WIRE CUTTING PLIERS CUTTER, WIRE GAG, MOUTH SCISSORS, NASAL SCISSORS, UMBILICAL LARYNGEAL MIRRORS SUCTION UNIT SCISSORS, GENERAL, SURGICAL TRACHEAL RETRACTORS DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY SCALPEL, ONE-PIECE CONTRACTOR, SURGICAL SUCTION TUBES SAW CURETTE, SURGICAL, GENERAL USE NEEDLE, OPHTHALMIC SUTURING SCISSORS, OPHTHALMIC DUFNER ASPIRATION NEEDLE LIGATURE CONDUCTORS SAWS DOUBLE BLADED SAWS BLADE, SCALPEL EXTRACTOR FORCEPS TUBE INTRODUCTION FORK, TUNING MALLET RETRACTOR FORCEPS, DISCONNECT HOLDER, SPECULUM, ENT COTTON APPLICATORS HAND DRILLS FORCEPS, BIOPSY, NON-ELECTRIC Spatula NEEDLE, NEUROSURGICAL SUTURE SCISSORS, ORTHOPEDIC, SURGICAL ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY PROBE GENERAL BONE CHISELS BOUGIE, UROLOGICAL TWISTER, WIRE RETRACTOR, VAGINAL RETENTION DEVICE, SUTURE FORCEPS WIRE CLOSURE PERIOSTEAL RASPATORIES RASPS CURETTE, OPERATIVE FORCEPS, WIRE HOLDING COVER, BIOPSY FORCEPS FILE BONE, SURGICAL INSTRUMENT, CUTTING, ORTHOPEDIC MALLET, SURGICAL, GENERAL & PLASTIC SURGERY ORTHOPEDIC MANUAL SURGICAL INSTRUMENT SPECULUM, RECTAL INSTRUMENT, SURGICAL, NON-POWERED NEEDLE, BIOPSY, CARDIOVASCULAR Mictec Endoscopes and Accessories VEIN STRIPPERS Rasp DEPRESSOR, TONGUE, NON-SURGICAL CURETTE MANUAL SAWS SAWS SPECULUM, VAGINAL, METAL SOUND, URETHRAL, METAL OR PLASTIC KNIFE, AMPUTATION HOOK, FIBROID, GYNECOLOGICAL BELL, CIRCUMCISION Instrument Cast application DURA HOOKS HOOK, SURGICAL, GENERAL & PLASTIC SURGERY CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY HANDLE, SCALPEL MIRROR, MOUTH SCISSORS, WIRE CUTTING, ENT, STERILE FORCEPS, GENERAL & PLASTIC SURGERY FORCEPS, ENT SOUND, UTERINE STERNUM CHISELS FORCEPS, BIOPSY, GYNECOLOGICAL INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HDM	Packer, Uterine	Obstetrics/Gynecology	Class 1	884.4520	1994-09-29
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	1994-09-23
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	1994-09-22
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	1994-09-22
FHL	Scoop	Gastroenterology, Urology	Class 1	876.4730	1994-09-29
KBP	Hook, Tonsil Suturing	Ear, Nose, Throat	Class 1	874.4420	1994-09-29
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	1994-09-29
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	1994-09-28
KBD	Scissors, Nasal	Ear, Nose, Throat	Class 1	874.4420	1994-09-22
HDJ	Scissors, Umbilical	Obstetrics/Gynecology	Class 1	884.4520	1994-09-22
KAI	Mirror, Ent	Ear, Nose, Throat	Class 1	874.4420	1994-09-29
EBR	Unit, Suction Operatory	Dental	Class 1	872.6640	1994-09-29
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	1994-09-22
KCG	Dilator, Tracheal	Ear, Nose, Throat	Class 1	874.4420	1993-11-15
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1994-09-29
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	1994-09-29
FZR	Contractor, Surgical	General, Plastic Surgery	Class 1	878.4800	1994-09-29
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	1994-09-29
HSO	Saw	General, Plastic Surgery	Class 1	878.4800	1994-09-29
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	1994-09-29
HNM	Needle, Ophthalmic Suturing	Ophthalmic	Class 1	886.4350	1994-09-29
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	1994-09-22
GDM	Needle, Aspiration And Injection, Reusable	General, Plastic Surgery	Class 1	878.4800	1993-11-15
GEJ	Carrier, Ligature	General, Plastic Surgery	Class 1	878.4800	1994-09-29
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	1994-09-29
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	1994-09-29
HWB	Extractor	Orthopedic	Class 1	888.4540	1994-09-29
BWB	Forceps, Tube Introduction	Anesthesiology	Class 1	868.5780	1994-09-22
GWX	Fork, Tuning	Neurology	Class 1	882.1525	1994-09-28
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	1994-09-29
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1994-09-22
FJR	Forceps, Disconnect	Gastroenterology, Urology	Class 1	876.5540	1994-09-22
KAG	Holder, Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	1994-09-22
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	1994-09-29
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	1994-09-29
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	1994-09-22
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1994-09-29
HAS	Needle, Neurosurgical Suture	Neurology	Class 1	882.4650	1994-09-29
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	1994-09-22
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1994-09-28
HXB	Probe	Orthopedic	Class 1	888.4540	1993-11-15
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	1994-09-29
FAX	Bougie, Urological	Gastroenterology, Urology	Class 1	876.5520	1994-09-29
HXS	Twister, Wire	Orthopedic	Class 1	888.4540	1994-09-29
HDL	Retractor, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	1994-09-22
KGS	Retention Device, Suture	General, Plastic Surgery	Class 1	878.4930	1994-09-29
JXX	Forceps, Wire Closure, Ent, Sterile	Ear, Nose, Throat	Class 1	874.3540	1994-09-22
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	1994-09-29
EKE	Curette, Operative	Dental	Class 1	872.4565	1994-09-29
HYA	Forceps, Wire Holding	General, Plastic Surgery	Class 1	878.4800	1994-09-22
FFF	Cover, Biopsy Forceps	Gastroenterology, Urology	Class 1	876.1075	1994-09-22
EMI	File, Bone, Surgical	Dental	Class 1	872.4565	1994-09-29
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	1994-09-29
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1994-09-29
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	1994-09-28
FFQ	Speculum, Rectal	Gastroenterology, Urology	Class 1	876.4730	1994-09-22
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	1994-09-28
DWO	Needle, Biopsy, Cardiovascular	General, Plastic Surgery	Class 1	878.4800	1994-09-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2009-12-29
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2009-12-29
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2009-12-29
GAI	Stripper, Vein, Reusable	General, Plastic Surgery	Class 1	878.4800	1994-09-29
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1994-09-29
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	1994-09-29
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	1994-09-29
GDR	Saw, Manual And Accessories	General, Plastic Surgery	Class 1	878.4800	1994-09-29
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	1994-09-22
FBX	Sound, Urethral, Metal Or Plastic	Gastroenterology, Urology	Class 1	876.5520	1994-09-29
GDN	Knife, Amputation	General, Plastic Surgery	Class 1	878.4800	1994-09-23
HDE	Hook, Fibroid, Gynecological	Obstetrics/Gynecology	Class 1	884.4520	1994-09-29
FHG	Bell, Circumcision	Obstetrics/Gynecology	Class 2	884.4530	1994-09-29
LGG	Instrument, Cast Application/Removal, Manual	Orthopedic	Class 1	888.5980	1994-09-29
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1994-09-29
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1994-09-22
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	1994-09-29
EAX	Mirror, Mouth	Dental	Class 1	872.4565	1994-09-29
JYA	Scissors, Wire Cutting, Ent, Sterile	Ear, Nose, Throat	Class 1	874.3540	1994-09-22
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1994-09-22
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	1994-09-22
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	1994-09-29
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	1994-09-29
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	1994-09-22
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	1994-09-28

Official Correspondent

ANNETTE DUFNER

US Agent Details

Angelika Scherp Business: BUSINESS SUPPORT INTERNATIONAL Email: info@bsi-fda.com Phone: (812) 6125626

Related Public Records

Same Entity

DUFNER 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
K953012	Boston Surgical Products, Inc.	DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS	1995-07-12
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
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.
Z-0034-2012	X Spine Systems Inc	1	Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612278. Last updated year: 2026. Please use registration number 9612278 when referencing this establishment in official correspondence.