BEUDAMED
    8 results · 18ms · 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.

    MEZLIN DIAGNOSTIC REAGENT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ACCOLADE II HIP STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GC FUJI ORTHO BAND PASTE PAK

    FDA 510(k)
    FDA Class 2 ·Dental

    AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS (MN)·Product code OTP·May 20, 2014

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 4, 2012

    ECHELON 60 ENDOPATH STAPLER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GDW·September 12, 2007

    1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Telephone # +1 201-831-5000 Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France Intended for cementless application in total or hemiarthroplasty procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·December 18, 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