BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE

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

    NICOLET CORTICAL STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    API UNISCEPT MIC/UNISCEPT MICRO-MIC

    FDA 510(k)
    FDA Class 2 ·Microbiology

    LEAD MODEL 304

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·February 21, 2013

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·January 20, 2011

    SINGLE TRIGGER ROTARY

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·August 1, 2014

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HTJ·July 28, 2017

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HTJ·March 10, 2017

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024