BEUDAMED
    14 results · 26ms · Sources: EU EUDAMED, US FDA

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    RAISED TOILET SEATS & NAIL CLIPPERS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    TEST PANEL FOR PRESUMP. ID/BACT. ORG

    FDA 510(k)
    FDA Class 1 ·Microbiology

    LANX FUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FLOEY CATHETER W TEMP

    FDA Adverse Event
    Injury ·DEGANIA SILICONE LTD·Product code DRF·October 17, 2017

    FOLEY CATHETER W TEMP

    FDA Adverse Event
    Malfunction ·DEGANIA SILICONE LTD.·Product code DRF·August 10, 2017

    FOLEY CATHETER W TEMP

    FDA Adverse Event
    Malfunction ·DEGANIA SILICONE LTD.·Product code DRF·August 10, 2017

    FOLEY CATHETER W TEMP

    FDA Adverse Event
    Malfunction ·DEGANIA SILICONE LTD.·Product code KOD·July 7, 2017

    3.5MM LCP PROXIMAL TIBIA PLATE LOW BEND 12 HOLES/180MM/LEFT

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code HRS·May 25, 2014

    CHARGING SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 5, 2012

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code DYE·September 10, 2010

    FOLEY CATHETER W TEMP

    FDA Adverse Event
    Malfunction ·MMJ SA DE CV (USD)·Product code DRF·November 9, 2018

    Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·May 16, 2018

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017