FDA Device Intelligence
HomeDavol Inc. › Phasix

Phasix

Davol Inc. · Model 1191020 · UDI-DI 00801741107573

OOD Prescription
10
510(k) clearances
1,213
Adverse events (7 deaths)
1
Recalls
12
Facilities

Description

Phasix Mesh, 4" x 8" (10 cm x 20 cm), Rectangle

Recalls

DateFirmReason
2016-11-21Tepha IncorporatedEndotoxin 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 docs
Data 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.