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

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    Getinge Series Warming Cabinet

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    GEN_2 MECHANICAL WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ELTA WOUND CLEANSER

    FDA 510(k)
    FDA Unclassified ·Unknown

    ITREL 3

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 7, 2015

    CAPSURE SP NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 8, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

    RIATA PASSIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·October 8, 2014

    D902 LILLIPUT ECMO M PHISIO

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·April 7, 2022

    LILLIPUP PMP, LILLIPUT PMP INTEGRATED

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·June 27, 2022

    ITREL 3

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code LGW·August 15, 2016

    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

    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

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

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