Data / Medical devices / Germany / PFM Medical GmbH
PFM Medical GmbH: FDA-registered device maker in COLOGNE North Rhine-Westphalia, Germany, 2 510(k) clearances
PFM Medical GmbH is registered with the FDA (registration 9617465) in COLOGNE North Rhine-Westphalia, Germany. It lists 8 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 29, 2003. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9617465
- FEI number
- 3003769549
- Address
- Wanklestrasse 60, COLOGNE North Rhine-Westphalia, Germany, 50996
- Owner or operator
- PFM MEDICAL GMBH (9035772)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer
- First device listed
- December 21, 1999
- Registered through
- 2026
- Brand names listed
- Introducer, MULTISNARE, Stretching Table, TiMESH, pfm Forceps
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bottle, Collection, Vacuum | KDQ | 2 | Complaint file establishment, Exporter to the US | accessdata.fda.gov |
| Catheter, Embolectomy | DXE | 2 | Complaint file establishment | accessdata.fda.gov |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Complaint file establishment, Exporter to the US | accessdata.fda.gov |
| Mesh, Surgical | FTM | 2 | Exporter to the US | accessdata.fda.gov |
| Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects | OXJ | 2 | Exporter to the US | accessdata.fda.gov |
| Mesh, Surgical, Polymeric | FTL | 2 | Exporter to the US | accessdata.fda.gov |
| Table, Slide Warming | IEG | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 29, 2003 | K031225 | TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004 | FTL | Substantially Equivalent | Gfe Medizintechnik GmbH | accessdata.fda.gov |
| January 24, 2002 | K011783 | MULTI-SNARE SET | DXE | Substantially Equivalent | Pfm Produkte Fur Die Medizin AG | accessdata.fda.gov |
Compare with other makers
- All makers of Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
- All makers of Mesh, Surgical, Polymeric
- All makers of Mesh, Surgical
- All makers of Introducer, Catheter
- All makers of Bottle, Collection, Vacuum
- All makers of Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Updated September 29, 2003. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.