BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

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    Power Wheelchair (JJW-6001)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25 LASER SYSTEM (25 WATT)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LATERAL VBR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD VACUTAINER CPT CELL PREPARATION TUBE WITH SODIUM HEPARIN

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·June 10, 2020

    EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 11.5MM LENGTH

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·October 21, 2021

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    UNKNOWN DEPUY TIBIA

    FDA Adverse Event
    Injury ·DEPUY WARSAW·Product code JWH·September 9, 2011

    8010042-2008-00136

    FDA Adverse Event
    Malfunction ·Product code CBK·August 26, 2008

    1.55MM X 10MM FLUTED TWIST DRL

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013

    BD VACUTAINER CPT CELL PREPARATION TUBE WITH SODIUM HEPARIN

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·July 31, 2020

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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