11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NA
FDA UDI
Exactech, Inc.·10885862606983·ANT APPROACH CORKSCREW
TORNIER AEQUALIS REVERSE SHOLDER PROSTHESIS
FDA Adverse Event
Malfunction
·TORNIER INC.·Product code HSD·June 18, 2009
LIFECARD CF 7 DAY
FDA 510(k)
FDA Class 2
·Cardiovascular
NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR BLUE
FDA 510(k)
FDA Class 1
·General Hospital
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 8, 2013
INSIGNIA
FDA Adverse Event
Injury
·GUIDANT CLONMEL IRELAND·Product code NVZ·April 6, 2011
CONTAK RENEWAL 4
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008
VIASYS
FDA Adverse Event
Other
·CAREFUSION 207, INC·Product code CBK·October 27, 2009
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