7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES
FDA 510(k)
FDA Class 2
·Neurology
CIRRUS NEBULIZER-DELUXE KIT
FDA 510(k)
FDA Class 1
·Anesthesiology
EMIT NORTRIPTYLINE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 2, 2014
SM104 MSERIES W5TH WHL
FDA Adverse Event
Malfunction
·STRYKER CORP. MEDICAL DIVISION·Product code FPO·October 13, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 16, 2012
SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024