BEUDAMED
    12 results · 18ms · Sources: EU EUDAMED, US FDA

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    Access Rubella IgG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Philips

    FDA UDI
    Sbo Hearing A/S·05714464091379·HEARLINK 1700 BTE PP GR/DG

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776209131·LAP NH SELFRIGHTING NEEDLE TIP

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180169043·5MM, 33CM NEEDLE HOLDER, SELF-RIGHTING NEEDLE T...

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·February 22, 2024

    OVA1 Next Generation

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    VERTEVIEW ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 14, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 16, 2011

    SOVEREIGN COMPACT CONSOLE

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HQC·July 26, 2013

    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 F102, F110, F111. 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