8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ADULT PERM-CATH 40CM.
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AMALGAM DISPENSER
FDA 510(k)
FDA Class 1
·Dental
Velofix(tm) Interbody Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
FOLFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·June 13, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 15, 2010
P.F.C.* FLUT TIB ROD 75X16MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·December 13, 2012
Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)
FDA Enforcement
Class III
·Terminated·GSK Consumer Healthcare·July 20, 2016
Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)
FDA Recall
Terminated
·GSK Consumer Healthcare·Product code N/A·April 25, 2016