BEUDAMED
    15 results · 22ms · Sources: EU EUDAMED, US FDA

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    Vario 8/18/ci

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

    LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SONIXTABLET ULTRASOUND SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    PEDICLE SCREW REDUCTION PEDICLE SCREW 6X40

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·May 29, 2019

    CART 9733856 S7 STAFF ASSEMBLED 110V

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 18, 2019

    HALO XP ELECTROPHYSIOLOGY CATHETER WITH AUTO ID

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·June 13, 2012

    CART 9733856 S7 STAFF ASSEMBLED 110V

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 6, 2019

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·February 12, 2018

    CART 9734056 S7 STAFF SHRT 100-120V INTL

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 18, 2019

    STEALTHSTATION® S7

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·March 18, 2019

    ATTAIN ABILITY PLUS

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

    FLEXCATH STEERABLE SHEATH

    FDA Adverse Event
    Malfunction ·MEDTRONIC CRYOCATH LP·Product code DRA·July 7, 2011

    GE OEC 2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 11, 2008

    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 Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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