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

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    AirFit F20

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FORMATK MAGMA PLATFORM LASER

    FDA Adverse Event
    Injury ·FORMATK SYSTEMS LTD.·Product code GEX·December 19, 2019

    HUMAPEN MEMOIR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 28, 2024

    FORMATK MAGMA PLATFORM

    FDA Adverse Event
    Malfunction ·FOMATK SYSTEMS, LTD·Product code GEX·January 8, 2020

    ATTAIN ABILITY

    FDA Adverse Event
    Malfunction ·MPRI·Product code OJX·June 8, 2013

    COGNIS

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 7, 2011

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    FDA Adverse Event
    Injury ·COVIDIEN LP, FORMERLY KNOW AS VALLEYLAB, A DIVISON·Product code ODR·August 6, 2008

    Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·February 18, 2015

    FUSION 8MM-40CM UNSUPP PERIPHERAL GRAFT

    FDA Adverse Event
    Malfunction ·MAQUET CV·Product code DSY·February 8, 2017

    ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO300, PSDA-10PPX, PSDA-10BUP, PSD-12BUP, PSD-10M, PSCupA-6MB-W, PSCup-10MMO300, PSD-5AB, PSD-10CMO3, PSCupA-10MO, PSCupA-12M-W I-DXA-1127-023, PSCupA-12TBU.

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    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