BEUDAMED
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    EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    EZ-ON CONDOM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    FOWLER ENDOCURETTE, MODEL CUR-XXX

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    LARGE SUTURECUT NEEDLEDRIVER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·March 13, 2013

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·February 8, 2011

    JOSTENT GRAFTMASTER

    FDA Adverse Event
    Death ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·February 25, 2008

    Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. PRECIMED, Torque Limiting Adaptor, Non Sterile.. Customer Number/Model: 00-2360-080-00 T10232, T116245 T116245, TLA025-25 TLA025-25, 00-2360-080-05 T10233, MAC21003 T116430, TLA025-30 TLA025-30, MAC21001 T112972, MAC21001 T13621, TLA025-20 TLA025-20.

    FDA Enforcement
    Class II ·Terminated·Greatbatch Medical·June 8, 2016

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    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