9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MYCOAKT M KANSASII CULTURE ID KIT
FDA 510(k)
FDA Class 1
·Microbiology
ReLine
FDA UDI
Nuvasive, Inc.·00195377072825·RELINE C Ti Rod, 3.5x50mm Pre Bent
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690121930·Femoral Posterior Augment Trial, Sz 3+, 5mm
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690121374·Femoral Augment Posterior, Size 3+, 5mm
VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws
FDA 510(k)
FDA Class 2
·Orthopedic
HEMCON BANDAGE AND HEMCON BANDAGE OTC
FDA 510(k)
FDA Unclassified
·Unknown
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE HEALTH SOLUTIONS INC.·Product code LZG·January 18, 2013
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·December 30, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 17, 2014