9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SIMPLATE PEDIATRIC
FDA 510(k)
FDA Class 2
·Hematology
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909117452·REVELATION DIAMOND 379-018F - 5 PACK
VITEK® 2 AST-GN67 TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·September 24, 2018
HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER
FDA 510(k)
FDA Class 2
·Cardiovascular
ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL CO.·Product code MTA·November 18, 2010
UNKNOWN
FDA Adverse Event
Malfunction
·GUIDANT ANGLETON/ST. PAUL·Product code NHW·January 11, 2013
ACUITY
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·July 3, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024