FDA Registration
Active
🇩🇪 Germany
FEHLING INSTRUMENTS GmbH
Reg #: 9615005
·
FEI: 3001286223
·
Expires 2026
Products
21
Proprietary Names
22
Establishment Types
5
Classifications
21
Registration Details
- Registration Name
- FEHLING INSTRUMENTS GmbH
- Registration Number
- 9615005
- FEI Number
- 3001286223
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Seligenstaedter Str. 100
- City
- KARLSTEIN Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K220981
Owner / Operator
- Firm Name
- FEHLING INSTRUMENTS GmbH
- Operator Number
- 9004104
- Address
- Seligenstaedter Str. 100
- City
- Karlstein
- State
- Bavaria
- Postal Code
- 63791
- Country
- DE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2012-07-24 |
| Dilator, Vessel, Surgical | DWP | Class 2 | Cardiovascular | No | 2024-07-12 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2012-07-19 |
| Instrument, Microsurgical | GZX | Class 1 | Neurology | No | 2012-07-19 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 1998-05-14 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 1998-05-15 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 1998-05-15 |
| Probe, Ent | KAK | Class 1 | Ear, Nose, Throat | No | 2012-07-19 |
| Device, Biopsy, Endomyocardial | DWZ | Class 2 | Cardiovascular | No | 2017-06-08 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2012-07-19 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2012-07-19 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2012-07-19 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2012-07-24 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2015-07-31 |
| Rongeur, Manual | HAE | Class 2 | Neurology | No | 2016-08-10 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 1998-05-15 |
| Sizer, Heart-Valve, Prosthesis | DTI | Class 1 | Cardiovascular | No | 2012-07-24 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2012-07-19 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2012-07-24 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2009-11-19 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2012-07-24 |
Proprietary Names
knot tying inst.
SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe
tray
microsurgical inst
MICS MV Superflex Atrial Retractor
surgical inst
chisel
RONGEUR
Probe
Fehling Biopsy Forceps
retractor
surgical instrument
scissors
screw driver
Surgical Cannula
manual rongeur
FORCEPS
sizer
clamp
spatula
needleholder
surgical inst.
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility