BEUDAMED
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    MODIFICATION TO NITREX NITINOL GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Leksell Stereotactic System

    FDA UDI
    Elekta Solutions AB·07340201502730·FIXATION SCREW 55 MM, TITANIUM

    Myo/Wire II

    FDA UDI
    A & E MEDICAL CORPORATION·10841291101536·SS Suture, 6 per sleeve

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319735381·Soft Corn Spoon Knife, 5" (12.7cm) solid octago...

    KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MULTI PURPOSE FLEX ARRAY COIL : MODEL 235 SERIES

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRULIANT TIB IMP PS INSERT SZ 3.5 11MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·May 5, 2023

    VIASYS

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code CBK·March 12, 2013

    COMBI SET

    FDA Adverse Event
    Malfunction ·REYNOSA MANUFACTURING·Product code FJK·February 15, 2011

    PALOMAR STARLUX

    FDA Adverse Event
    Injury ·PALOMAR·Product code GEX·May 8, 2008

    VITEK® 2 AST-N350

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·December 17, 2018

    VITEK® 2 AST-N350

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·December 17, 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

    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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013