FDA Device Intelligence
Home › Advamedica Inc. › Ax-Surgi Surgical Hemostat

Ax-Surgi Surgical Hemostat

Advamedica Inc. · Model SH1006 · UDI-DI 00860012016648

POD Prescription
1
510(k) clearances
6
Adverse events
1
Recalls
15
Facilities

Description

Ax-Surgi Surgical Hemostat which is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It is intended to be placed temporarily for control of severely bleeding wounds such as surgical wounds and traumatic injuries.

Recalls

DateFirmReason
2021-10-14Beeken Biomedical, LLCEndotoxin levels exceeded allowable limits.

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.