BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RTE SNAPCONE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FHW·July 11, 2023

    TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TRANSAMERICA DIGITAL EMS

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    REAR TIP EXTENDER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code N/A·December 30, 2025

    RTE SNAPCONE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code FHW·February 17, 2021

    ENDO SMARTCAP

    FDA Adverse Event
    MEDIVATORS·Product code KOG·February 2, 2015

    IVT DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code KPE·May 2, 2013

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NKM·September 15, 2014

    MICRO SAGITTAL SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·April 19, 2011

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·December 29, 2015

    Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024