12 results
·
18ms
·
Sources: EU EUDAMED, US FDA
EQUITEST
FDA 510(k)
FDA Unclassified
·Unknown
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209105861·KIT, MCI WALK w' QL- BLK
Crimpable Stop
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746147197·ARCH STOP CRIMPABLE 2MM 036 ROUND 100/PKG
Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter
FDA 510(k)
FDA Class 2
·Cardiovascular
Passeo-18 Peripheral Dilation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
PASSEO-18 5/200/90
FDA Adverse Event
Malfunction
·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021
PASSEO-18 6/200/90
FDA Adverse Event
Malfunction
·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021
PASSEO-18 2.5/170/130
FDA Adverse Event
Malfunction
·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·January 20, 2021
ETHILON NYLON SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAR·June 5, 2014
SWEET TIP
FDA Adverse Event
Injury
·HISTORICAL PUERTO RICO·Product code NVN·October 4, 2010
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·November 29, 2012
GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022