11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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8NONE
FDA 510(k)
FDA Class 2
·General Hospital
InterStim™
FDA UDI
MEDTRONIC, INC.·20763000114064·NEEDLE 041839 FORAMN 5IN 18.5GA GLBL 2PK
DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C
FDA 510(k)
FDA Class 2
·Dental
AART GLUTEAL IMPLANT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
COMPLETE
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code LPN·April 17, 2020
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 8, 2013
BIPOLAR POROUS
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 6, 2011
EXTERNAL NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code EZW·January 11, 2022
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 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