Home › Tepha, Inc. › GalaFLEX 3DR
GalaFLEX 3DR
Tepha, Inc. · Model 100043-03 · UDI-DI 00810054980025
OOD
Prescription
1
510(k) clearances
1,213
Adverse events (7 deaths)
1
Recalls
12
Facilities
Description
GalaFLEX 3DR Scaffold, 6.4 cm x 18.5 cm, Medium Oval (Contents: 1)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-11-21 | Tepha Incorporated | Endotoxin values from testing of retains slightly exceeded the established specification. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.