BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Immunology

    NA

    FDA UDI
    MAKO SURGICAL CORP.·00848486020453·ACETABULAR REAMER ¿ 46mm

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221044860·Unitek(TM) Molar Band General Purpose Narrow Re...

    DIAMOND ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REMCORE REMOTE CONTROLLED OXYGEN REGULATOR

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·September 10, 2003

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 26, 2020

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 10, 2013

    COULTER LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·June 2, 2011

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008

    MINIMAX CEMENTLESS FEMORAL STEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 22, 2017

    TRUEMETRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·January 15, 2018

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024