8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
VYGON BALLOON FOR IDENTIFICATION OF EPIDURAL 193
FDA 510(k)
FDA Class 2
·Anesthesiology
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209104055·KIT, RANGE
EV-820 OTC Pain Relief TENS
FDA 510(k)
FDA Class 2
·Neurology
RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
CROSSLINK ANCHOR PG GLENOID 52
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWS·June 5, 2014
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code KPE·November 29, 2012
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code MGB·September 29, 2010
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021