21 results
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18ms
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Sources: EU EUDAMED, US FDA
PASS SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HANISCH MEDICAL
FDA UDI
Hanisch Medical Ltda·07898663493108·H26-LID F/INST.STANDER---AMBER
TAG
FDA UDI
Smith & Nephew, Inc.·03596010420046·DRVR TAG 3.7 ROD II ASCOPIC
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033477212·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033477205·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033477182·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033477175·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033477229·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033477199·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197191463·Freeman Adamson Facelift Retractor
4 pron...
Y2000 POCKET RESCUE
FDA 510(k)
FDA Class 2
·Anesthesiology
MIS IMPLANT SYSTEM DECIVE
FDA 510(k)
FDA Class 2
·Dental
SELECTSECURE
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NVN·August 21, 2018
HARMONIC SYNERGY* CURVED BLADE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·March 20, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 10, 2011
ICY HOT HEAT THERAPY PATCH
FDA Adverse Event
Other
·CHATTEM, INC.·Product code IMD·March 12, 2008
EVOLUT FX PLUS VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 24, 2025
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code BWC·September 4, 2019
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
Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·November 2, 2016