7 results
·
22ms
·
Sources: EU EUDAMED, US FDA
CARDIO PERFECT, CARDIO PERFECT MD
FDA 510(k)PTS PANELS LIPID PANEL TEST STRIPS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INOMAX DS (DELIVERY SYSTEM)
FDA Adverse Event
Malfunction
·INO THERAPEUTICS, LLC/IKARIA·Product code MRN·November 12, 2010
ARTICULEZE M HEAD 36MM +12
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·January 18, 2013
1/4 INCH DRILL WITH JACOBS CHUCK
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·July 9, 2014
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·October 13, 2021