8 results
·
22ms
·
Sources: EU EUDAMED, US FDA
SILASTIC TENDON PASSER H.P.
FDA 510(k)
FDA Class 1
·Orthopedic
Xtractor device
FDA 510(k)
FDA Class 2
·Cardiovascular
FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY
FDA 510(k)
FDA Class 2
·Hematology
IMPELLA RP
FDA Adverse Event
Death
·ABIOMED, INC.·Product code PYX·October 15, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 15, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC. USA·Product code LFR·October 23, 2007
SPRINT QUATTRO
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, 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