7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MODIFICATION TO: ECLIPSE TREATMENT PLANNING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
RADIOLUCENT COLLES FRACTURE KIT
FDA 510(k)
FDA Class 2
·Orthopedic
NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120
FDA 510(k)
FDA Class 2
·Neurology
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)·Product code DQK·April 22, 2013
UNICEL® DXI 600
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·April 28, 2011
TACTILE GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code HAW·June 26, 2008
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·October 7, 2020