11 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
XPAND RADIOLUCENT CORPECTOMY SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70606651·Sprint II Brackets Roth .022" 1000 Brackets 3-5...
LIBERTY CYCLER SET, DUAL PT CONNECT
FDA Adverse Event
Malfunction
·REYNOSA PLANT·Product code FKX·April 25, 2014
TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER
FDA 510(k)
FDA Class 2
·General Hospital
TRANSAMERICA DIGITAL EMS
FDA 510(k)
FDA Class 2
·Physical Medicine
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 13, 2025
CERNER POWERORDERS
FDA Adverse Event
Malfunction
·CERNER CORP.·Product code OUG·March 26, 2013
STARCLOSE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·June 13, 2008
SMARTSET MV ENDURANCE 80G
FDA Adverse Event
Injury
·DEPUY CMW·Product code LOD·April 6, 2011
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018