7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
FLEXIBLE BIOPSY FORCEP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENSPLINTRX BONE FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Epic Biliary Endoscopic Stent System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RENAL- DISPOSABLE
FDA Adverse Event
Malfunction
·Product code FKX·October 16, 2010
S-ROM*SLEEVE PRX ZTT, 16F-SML
FDA Adverse Event
Injury
·DEPUY (IRELAND)·Product code LPH·December 13, 2012
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 17, 2014
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