BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    iLet ACE Pump

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Darby Dental Supply, LLC

    FDA UDI
    DARBY DENTAL SUPPLY, LLC·00889813054024·PVS IMP MAT MB 50ML FS UNFLAV

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197177191·RZ-Giraffe Biopsy Forceps 4x8mm,...

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QKP·November 6, 2020

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QKP·October 27, 2020

    PATHFORMER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ProBP 2400 Digital Blood Pressure Device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·December 4, 2023

    FORMULA AGGRESSIVE PLUS 4.0

    FDA Adverse Event
    HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS·Product code NBH·November 7, 2014

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·September 19, 2011

    RIGHT - NAV COMPATIBLE DUAL-OFFSET ACCOLADE RASP HANDLE

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LXH·July 29, 2013

    BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QKP·November 6, 2020

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014