7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
LIC TURNOVER BED
FDA 510(k)
FDA Class 2
·General Hospital
ABL90
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NORIAN SRS BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Orthopedic
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·October 31, 2012
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 11, 2013
ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAF
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code JCT·August 24, 2010
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024