7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
CLIRANS TAF 120 HOLLOW FIBER DIALYZ. &
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE
FDA 510(k)
FDA Class 2
·Neurology
SOFIA DISTAL ACCESS CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 25, 2014
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·November 14, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·September 10, 2010
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024