BEUDAMED
    11 results · 25ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VARIAX

    FDA UDI
    Stryker GmbH·07613327123395·Upper Tray Wrist Add-on, 2 Level

    N/A

    FDA UDI
    Tyber Medical, LLC·M695M9402210·

    SpiritMB

    FDA UDI
    ORMCO CORPORATION·00889989007022·ID G - Twin - Upper-Left Lateral - Red

    SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SPECTRALIS HRA+OCT and variants

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    BIPOLAR PK WORKING ELEMENT

    FDA Adverse Event
    Injury ·GYRUS ACMI INC·Product code FDC·June 19, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 2, 2013

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORP·Product code MKJ·December 9, 2010

    Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.

    FDA Enforcement
    Class II ·Terminated·Capintec Inc·April 1, 2020

    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