13 results
·
29ms
·
Sources: EU EUDAMED, US FDA
BISX
FDA 510(k)
FDA Class 2
·Neurology
GD
FDA UDI
General Devices·00862186000379·The CAREpoint Workstation (Version 1 and 2) com...
GLOBAL BY <GENX> BLASTOCYST MEDIA
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HARDYDISK, PIPERACILLIN, 100MCG
FDA 510(k)
FDA Class 2
·Microbiology
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·October 8, 2013
CD HORIZON
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·August 11, 2020
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWP·December 29, 2010
ARTICULEZE M HEAD 36MM -2
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code JDI·April 8, 2013
POWERED WHEELCHAIR
FDA Adverse Event
Other
·INVACARE·Product code ITI·March 24, 2011
NONE
FDA Adverse Event
Injury
·OBTECH MEDICAL SARL·Product code LTI·May 8, 2008
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·July 6, 2020
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPT·July 29, 2025
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018