BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    DOBBHOFF(R) BIPOLAR HEMOSTATIC PROBE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·34546540244483·BONE SCREWS, CROSS-FIT, SELF-TAPPING

    Malibu

    FDA UDI
    Seaspine Orthopedics Corporation·10889981080716·Polyaxial Screw Driver Shaft, Jacobs

    VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ORTHO DEVELOPMENT ORION-I EMF SYSTEM

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

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·December 2, 2010

    DA VINCI S SURGICAL SYSTEM

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·January 11, 2013

    ACCU-CHEK ® AVIVA COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·July 3, 2014

    UNKNOWN

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code DTK·December 2, 2015

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    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