8 results
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24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CREA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GORE TRI-LOBE BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ResCUBE Ligament Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·February 27, 2013
RESOLUTION CLIP CLIPPING DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KOG·August 5, 2014
INTEGRATED APD SET W/CASSETTE3 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 8, 2011
ARCHITECT C16000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JJE·May 10, 2019
GORE® TRI-LOBE BALLOON CATHETER
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DQY·February 24, 2021