BEUDAMED
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    K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C

    FDA 510(k)
    FDA Class 2 ·Immunology

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809871111·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND CLOSED...

    CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIQ·February 7, 2011

    VOYAGER NC CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·February 7, 2011

    TAXUS® LIBERTÉ®

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·April 9, 2013

    UNKNOWN PRODUCT

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

    VITALITY 2 VR

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

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code MGB·December 7, 2021

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·February 7, 2011

    PERCLOSE¿ PROSTYLE¿

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR INC.·Product code MGB·July 23, 2025

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; 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