7 results
·
28ms
·
Sources: EU EUDAMED, US FDA
VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR
FDA 510(k)
FDA Class 1
·Cardiovascular
NEXT GENERATION ANTERIOR CERVICAL PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Continuous Single Culture -NX (CSCM-NX)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ROTALINK? ADVANCER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code MCX·April 24, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 1, 2012
CL CONTINU-FLO SOLN SET, 2 LAVS, L/L
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·July 27, 2010
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022