BEUDAMED
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    FACT PLUS ONE-STEP PREGNANCY TEST KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496042280·ALISEA 70, SIZE M, NERO, GRADUATED COMPRESSION ...

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809871722·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND CLOSED...

    TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    PENUMA IMPLANT

    FDA Adverse Event
    Injury ·NATIONAL MEDICAL DEVICES INC.·Product code MIB·March 1, 2018

    GREENLIGHT HPS BPH FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS·Product code GEX·April 1, 2013

    CONTAK RENEWAL

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 6, 2011

    CONTAK RENEWAL 4

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

    STOCKERT CORONARY PERFUSION CANNULAE

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DWF·March 7, 2019

    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, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 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