11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICRODERM, MODEL/VERSION 3.5
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER
FDA 510(k)
FDA Class 2
·Orthopedic
CBYON SURGICAL OPERATING SYSTEM (SOS)
FDA 510(k)
FDA Class 2
·Neurology
SONA PILLOW
FDA Adverse Event
Other
·SLEEP DEVICES, INC.·Product code MYB·May 4, 2007
SONA PILLOW
FDA Adverse Event
Other
·SLEEP DEVICES, INC.·Product code MYB·June 18, 2007
ISODUR PROSTHESIS HEAD 12/14 28MM M
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code LPH·January 16, 2015
RESOLUTE INTEGRITY RX
FDA Adverse Event
Injury
·MEDTRONIC·Product code NIQ·April 2, 2013
STARCLOSE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·May 8, 2008
APEX BALLOON CATHETER
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·April 5, 2011
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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018