BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    POLYETHYLENE MONITORING CONNECTORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TwinFix

    FDA UDI
    Stryker GmbH·04546540362100·CANNULATED COMPRESSION SCREW

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971666·

    SOLEA

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

    LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·April 21, 2017

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·May 14, 2014

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code INK·October 10, 2012

    DURATA STS OPTIM ACTIVE FIXATION, SJ4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2010

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    ACCOLADE SR SL MRI (Model L310)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025