7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ABBOTT IMX LH
FDA 510(k)
FDA Class 1
·Clinical Chemistry
STOCKERT-SHILEY HANDHELD REMOTE CONTROL INTRACARDI
FDA 510(k)
FDA Class 2
·Cardiovascular
HYPO SUTURE
FDA 510(k)
FDA Class 2
·General Hospital
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·June 19, 2014
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code MCX·October 27, 2010
EXTENSION BAR RAD 220 SIZ 10 TAN GOLD
FDA Adverse Event
Injury
·SYNTHES·Product code MDI·December 21, 2012
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024