8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
OPTICAL VALVULOTOME
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNCHRON (R) SYSTEMS CREATININE REAGENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code CGX·July 2, 2011
JANUS ATAC ENG ANALYSIS SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
COULTER(R) MH010
FDA 510(k)
FDA Class 2
·Hematology
GREENLIGHT ADDSTAT
FDA Adverse Event
Other
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·November 18, 2010
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·January 14, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 3, 2014
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