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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    INSERTION

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526827936·ACHIMED ACHILLES SUPP BLACK V

    i-ED COIL

    FDA UDI
    KANEKA CORPORATION·04540778177079·The i-ED COIL is used for vascular embolization...

    TEMPUS CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OPEN SPINE CLAMP, TITANIUM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·January 17, 2013

    DUROM US ACETABULAR COMPONENT 60/54 T

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·December 3, 2010

    ZEPHYR DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·July 8, 2014

    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