8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
VAS-CATH PARALLEL DUAL LUMAN JUGULAR CANNUAL CATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RADIOPAQUE 7 FRX 12-POLYURETHANE MULTI
FDA 510(k)
FDA Class 2
·Cardiovascular
FLOW-PAC CALCIUM REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 2, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 8, 2012
EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code KRH·September 24, 2010
Pipeline Flex Embolization Device
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021
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