FDA Registration
Active
🇩🇪 Germany
DUFNER INSTRUMENTE GMBH
Reg #: 9612278
·
FEI: 3002806862
·
Expires 2026
Products
104
Proprietary Names
113
Establishment Types
1
Classifications
104
Registration Details
- Registration Name
- DUFNER INSTRUMENTE GMBH
- Registration Number
- 9612278
- FEI Number
- 3002806862
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- FOEHRENSTR. 9
- City
- TUTTLINGEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K002877
Owner / Operator
- Firm Name
- DUFNER INSTRUMENTE GMBH
- Operator Number
- 8010266
- Address
- FOEHRENSTR. 9, --
- City
- TUTTLINGEN
- State
- Baden-Wurttemberg
- Postal Code
- 78532
- Country
- DE
- Correspondent
- ANNETTE - DUFNER
US Agent
- Business Name
- BUSINESS SUPPORT INTERNATIONAL
- Contact Name
- Angelika Scherp
- Address
- 271 WALDROUP RD.
- City
- HOT SPRINGS
- State
- NC
- ZIP
- 28743
- Country
- US
- [email protected]
- Phone
- 812 6125626
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Packer, Uterine | HDM | Class 1 | Obstetrics/Gynecology | No | 1994-09-29 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 1994-09-23 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 1994-09-22 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 1994-09-22 |
| Scoop | FHL | Class 1 | Gastroenterology, Urology | No | 1994-09-29 |
| Hook, Tonsil Suturing | KBP | Class 1 | Ear, Nose, Throat | No | 1994-09-29 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 1994-09-29 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 1994-09-28 |
| Scissors, Nasal | KBD | Class 1 | Ear, Nose, Throat | No | 1994-09-22 |
| Scissors, Umbilical | HDJ | Class 1 | Obstetrics/Gynecology | No | 1994-09-22 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 1994-09-29 |
| Unit, Suction Operatory | EBR | Class 1 | Dental | No | 1994-09-29 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 1994-09-22 |
| Dilator, Tracheal | KCG | Class 1 | Ear, Nose, Throat | No | 1993-11-15 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 1994-09-29 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 1994-09-29 |
| Contractor, Surgical | FZR | Class 1 | General, Plastic Surgery | No | 1994-09-29 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 1994-09-29 |
| Saw | HSO | Class 1 | General, Plastic Surgery | No | 1994-09-29 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 1994-09-29 |
| Needle, Ophthalmic Suturing | HNM | Class 1 | Ophthalmic | No | 1994-09-29 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 1994-09-22 |
| Needle, Aspiration And Injection, Reusable | GDM | Class 1 | General, Plastic Surgery | No | 1993-11-15 |
| Carrier, Ligature | GEJ | Class 1 | General, Plastic Surgery | No | 1994-09-29 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 1994-09-29 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 1994-09-29 |
| Extractor | HWB | Class 1 | Orthopedic | No | 1994-09-29 |
| Forceps, Tube Introduction | BWB | Class 1 | Anesthesiology | No | 1994-09-22 |
| Fork, Tuning | GWX | Class 1 | Neurology | No | 1994-09-28 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 1994-09-29 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 1994-09-22 |
| Forceps, Disconnect | FJR | Class 1 | Gastroenterology, Urology | No | 1994-09-22 |
| Holder, Speculum, Ent | KAG | Class 1 | General, Plastic Surgery | No | 1994-09-22 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 1994-09-29 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 1994-09-29 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 1994-09-22 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 1994-09-29 |
| Needle, Neurosurgical Suture | HAS | Class 1 | Neurology | No | 1994-09-29 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 1994-09-22 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 1994-09-28 |
| Probe | HXB | Class 1 | Orthopedic | No | 1993-11-15 |
| Chisel, Bone, Surgical | EML | Class 1 | Dental | No | 1994-09-29 |
| Bougie, Urological | FAX | Class 1 | Gastroenterology, Urology | No | 1994-09-29 |
| Twister, Wire | HXS | Class 1 | Orthopedic | No | 1994-09-29 |
| Retractor, Vaginal | HDL | Class 1 | Obstetrics/Gynecology | No | 1994-09-22 |
| Retention Device, Suture | KGS | Class 1 | General, Plastic Surgery | No | 1994-09-29 |
| Forceps, Wire Closure, Ent, Sterile | JXX | Class 1 | Ear, Nose, Throat | No | 1994-09-22 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 1994-09-29 |
| Curette, Operative | EKE | Class 1 | Dental | No | 1994-09-29 |
| Forceps, Wire Holding | HYA | Class 1 | General, Plastic Surgery | No | 1994-09-22 |
| Cover, Biopsy Forceps | FFF | Class 1 | Gastroenterology, Urology | No | 1994-09-22 |
| File, Bone, Surgical | EMI | Class 1 | Dental | No | 1994-09-29 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 1994-09-29 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 1994-09-29 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 1994-09-28 |
| Speculum, Rectal | FFQ | Class 1 | Gastroenterology, Urology | No | 1994-09-22 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 1994-09-28 |
| Needle, Biopsy, Cardiovascular | DWO | Class 1 | General, Plastic Surgery | No | 1994-09-29 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2009-12-29 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2009-12-29 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2009-12-29 |
| Stripper, Vein, Reusable | GAI | Class 1 | General, Plastic Surgery | No | 1994-09-29 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 1994-09-29 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 1994-09-29 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 1994-09-29 |
| Saw, Manual And Accessories | GDR | Class 1 | General, Plastic Surgery | No | 1994-09-29 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 1994-09-22 |
| Sound, Urethral, Metal Or Plastic | FBX | Class 1 | Gastroenterology, Urology | No | 1994-09-29 |
| Knife, Amputation | GDN | Class 1 | General, Plastic Surgery | No | 1994-09-23 |
| Hook, Fibroid, Gynecological | HDE | Class 1 | Obstetrics/Gynecology | No | 1994-09-29 |
| Bell, Circumcision | FHG | Class 2 | Obstetrics/Gynecology | No | 1994-09-29 |
| Instrument, Cast Application/Removal, Manual | LGG | Class 1 | Orthopedic | No | 1994-09-29 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 1994-09-29 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 1994-09-22 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 1994-09-29 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 1994-09-29 |
| Scissors, Wire Cutting, Ent, Sterile | JYA | Class 1 | Ear, Nose, Throat | No | 1994-09-22 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 1994-09-22 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 1994-09-22 |
| Sound, Uterine | HHM | Class 1 | Obstetrics/Gynecology | No | 1994-09-29 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 1994-09-29 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 1994-09-22 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 1994-09-28 |
| Clamp, Uterine | HGC | Class 1 | Obstetrics/Gynecology | No | 1994-09-22 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 1994-09-29 |
| Hook, Gastro-Urology | FHB | Class 1 | Gastroenterology, Urology | No | 1994-09-29 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 1994-09-22 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 1994-09-29 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 1993-11-15 |
| Hook, Tracheal | KCH | Class 1 | Ear, Nose, Throat | No | 1994-09-29 |
| Clamp, Non-Electrical | FFN | Class 1 | Gastroenterology, Urology | No | 1994-09-22 |
| Scissors, Episiotomy | HDK | Class 1 | Obstetrics/Gynecology | No | 1994-09-22 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 1994-09-22 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 1993-11-15 |
| Trephine | HWK | Class 1 | Orthopedic | No | 1994-09-29 |
| Dilator, Rectal | FFP | Class 1 | Gastroenterology, Urology | No | 1994-09-29 |
| Pin, Retentive And Splinting, And Accessory Instruments | EBL | Class 1 | Dental | No | 1994-09-29 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 1994-09-28 |
| Curette, Uterine | HCY | Class 1 | Obstetrics/Gynecology | No | 1994-09-29 |
| Probe, Rectal, Non-Powered | EXX | Class 1 | Gastroenterology, Urology | No | 1994-09-29 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 1994-09-23 |
| Scissors, Ear | JZB | Class 1 | Ear, Nose, Throat | No | 1994-09-22 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 1994-09-28 |
| Mirror, Headband, Ophthalmic | HKF | Class 1 | Ophthalmic | No | 1994-09-29 |
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
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
SPECULUM, VAGINAL, METAL
SOUND, URETHRAL, METAL OR PLASTIC
KNIFE, AMPUTATION
HOOK, FIBROID, GYNECOLOGICAL
BELL, CIRCUMCISION
Instrument
Cast application
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
CLAMP, UTERINE
ELEVATOR, ENT
HOOK, GASTRO-UROLOGY
RETRACTOR, ALL TYPES
LIGATURE SUTURE INSTRUMENT
COMPLETE
OTOSCOPE SET
HOOK, TRACHEAL
CLAMP, NON-ELECTRICAL
SCISSORS, EPISIOTOMY
SPECULUM, ENT
DUFNER DIMICRON
DUFNER TOP DUR
,MICRO
Needle Holder
TREPHINE
DILATOR, RECTAL
PIN, RETENTIVE AND SPLINTING, AND ACCESSORY INSTRUMENTS
BONE GOUGES
CURETTE, UTERINE
PROBE, RECTAL, NON-POWERED
KNIFE, ORTHOPEDIC
SCISSORS, EAR
TRAY, SURGICAL, INSTRUMENT
HEAD MIRRORS
Establishment Types
Manufacture Medical Device