BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    MICROPRIME

    FDA 510(k)
    FDA Class 2 ·Dental

    DeBakey Vascular Clamps

    FDA UDI
    KOROS U.S.A., INC.·10840199540171·DeBakey Vascular Clamps 60 Degree Angle 10cm Ja...

    MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.12-16 UG/ML)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    HALA'TUS 1 OXYGENATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code CGA·July 27, 2016

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MPRI·Product code NVY·February 9, 2013

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·January 5, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 23, 2014

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·October 19, 2016

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·July 26, 2016

    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