BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    Tomey Cornea/Anterior Segment OCT (CASIA2)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180150195·5 MM DIA., 32 CM, HASSON GRASPER 3 PRONG CURVED...

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776209001·HASSON PRONG GRASPER CVD ALLIS TYPE

    NOVEL VBR SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Filbloc

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

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 23, 2014

    PRIMEADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·February 12, 2015

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 16, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·November 14, 2014

    ENTERRA

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LNQ·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