BEUDAMED
    11 results · 28ms · Sources: EU EUDAMED, US FDA

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    Spine Guidance Software, Stryker Q Guidance System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Philips

    FDA UDI
    Sbo Hearing A/S·05714464011308·PHILIPS HEARLINK 2.3.0 IOS

    VEO® Lateral Interbody Fusion System

    FDA UDI
    Choice Spine, LP·00840996134644·LATERAL,ANGLED CUP CURETTE ASSY

    BALFOUR CENTER BLADE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896077218·BALFOUR CENTER BLADE

    CONVERTORS SMS POLYOLEFIN GOWN

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

    MYOSURE CONTROL UNIT

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

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 3, 2014

    TIBIAL ALIGNMENT HANDLE

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·July 15, 2011

    PFC* MOD PLUS TIBIAL TRAY SZ 3

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·July 11, 2013

    Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2015

    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