BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    SEROMA-CATH CLOSE DRAINAGE SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MODIFIED FLOCATH PULMONARY ARTERY CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROTEIN TEST FOR URINE AND CSF

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    FDA Adverse Event
    Injury ·COOK INC·Product code MIH·November 22, 2010

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code FSA·January 9, 2013

    CONTAK RENEWAL TR

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NKE·July 1, 2014

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF 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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015