BEUDAMED
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    MICROALBUMIN MULTI-CALIBRATOR SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809871135·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND CLOSED...

    XORAN

    FDA Adverse Event
    Malfunction ·XORAN TECHNOLOGIES, INC.·Product code JAK·May 9, 2011

    HORIZONS REUSABLE HOT BIOPSY FORCEPS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·April 9, 2013

    TRIATHLON PRIM TIB BASEPLATE - CEMENTED

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·March 29, 2011

    ATRIAL J SELUTE PICOTIP

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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