FDA Registration
Active
🇩🇪 Germany
PFM Medical GmbH
Reg #: 9617465
·
FEI: 3003769549
·
Expires 2026
Products
8
Proprietary Names
5
Establishment Types
3
Classifications
8
Registration Details
- Registration Name
- PFM Medical GmbH
- Registration Number
- 9617465
- FEI Number
- 3003769549
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- WANKLESTRASSE 60
- City
- COLOGNE North Rhine-Westphalia
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K031225
Owner / Operator
- Firm Name
- PFM MEDICAL GMBH
- Operator Number
- 9035772
- Address
- 1916 Palomar Oaks Way
- City
- Carlsbad
- State
- CA
- Postal Code
- 92008
- Country
- US
- Correspondent
- Jessica Jho
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2020-08-24 |
| Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects | OXJ | Class 2 | General, Plastic Surgery | No | 2023-03-30 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2023-03-30 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 1999-12-21 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2018-10-09 |
| Table, Slide Warming | IEG | Class 1 | Pathology | No | 2018-01-17 |
| Catheter, Embolectomy | DXE | Class 2 | Cardiovascular | No | 2007-11-12 |
| Mesh, Surgical | FTM | Class 2 | General, Plastic Surgery | No | 2023-03-30 |
Proprietary Names
pfm Forceps
TiMESH
Introducer
Stretching Table
MULTISNARE
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device