7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
PERIDIAL PERITONEAL DIALYSIS TRAY
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Trevo NXT ProVue Retriever
FDA 510(k)
FDA Class 2
·Neurology
RESTORELLE POLYPROPYLENE MESH
FDA 510(k)
FDA Class 3
·Obstetrics/Gynecology
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·January 8, 2014
ANGIOSCULPT PTCA SCORING BALLOON CATHETER (EX)
FDA Adverse Event
Injury
·ANGIOSCORE, INC.·Product code NWX·October 10, 2012
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 10, 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