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

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    InMode Plus System

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

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704285451·

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111094712·SKLARCUT MAYO SCISS CVD 9"

    FORMATK MAGMA PLATFORM LASER

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

    RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH

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

    BILISOFT PHOTOTHERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·November 7, 2016

    FORMATK MAGMA PLATFORM

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

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·October 19, 2016

    SPRINT QUATTRO SECURE S

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

    COGNIS

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

    RIATA ST ACTIVE FIXATION

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

    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