7 results
·
28ms
·
Sources: EU EUDAMED, US FDA
CREATININE TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIAZYME CYSTATIN C POC TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
IMAGER II ANGIOGRAPHIC CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
GLUCOSE MONITORING SYS/KIT
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 15, 2014
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code NBW·October 22, 2007
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·October 31, 2012
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024