Data / Medical devices / Germany / PFM Medical Titanium GMBH
PFM Medical Titanium GMBH: FDA-registered device maker in NUREMBERG Bavaria, Germany, 1 510(k) clearance
PFM Medical Titanium GMBH is registered with the FDA (registration 3003936139) in NUREMBERG Bavaria, Germany. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 29, 2003. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3003936139
- Address
- Sudwestpark 42, NUREMBERG Bavaria, Germany, 90449
- Owner or operator
- PFM Medical Titanium (9055994)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 17, 2003
- Registered through
- 2026
- Brand names listed
- TiLoop, TiMESH
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mesh, Surgical | FTM | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects | OXJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Polymeric | FTL | 2 | 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 |
Compare with other makers
- All makers of Mesh, Surgical, Polymeric
- All makers of Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
- All makers of Mesh, Surgical
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.