9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
EPIC INTRODUCER SHEATH
FDA 510(k)
FDA Class 2
·Cardiovascular
Eye Shield
FDA UDI
KATENA PRODUCTS, INC.·00841668111154·FOX EYE SHIELD GARTER ASST COLOR PK/50
Eye Shield
FDA UDI
KATENA PRODUCTS, INC.·00841668111130·EYE SHIELD W/ GARTER ASSORTED PACK OF 50
FRAXEL II SR LASER SYSTEM AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
REPEL SURGICAL GLOVE LINERS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ZIMMER TRABECULAR METAL REVERSE LINER
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HSD·February 8, 2013
HEARTMATE II SYSTEM CONTROLLER
FDA Adverse Event
Malfunction
·THORATEC CORP·Product code DSQ·December 15, 2010
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 15, 2014
Custom Pack, part number AMS4776 Custom Pack, part number AMS4776(A Custom Pack, part number AMS5643 Custom Pack, part number AMS5643(A Custom Pack, part number AMS6012 Custom Pack, part number AMS6383 Custom Pack, part number PSS2135(B Custom Pack, part number PSS2798(B Custom Pack, part number PSS2798(C Custom Pack, part number PSS3463
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017