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

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    Kitazato OPU Needles

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    COLLAGEN DENTAL MENBRANE - CONFORMABLE II

    FDA 510(k)
    FDA Class 2 ·Dental

    NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)

    FDA 510(k)
    FDA Class 2 ·Neurology

    PAINSMART IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·May 13, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 15, 2011

    FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT

    FDA Adverse Event
    Malfunction ·CONVATEC INC·Product code KNT·July 16, 2014

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·September 23, 2016

    DEKA MOTUS AX

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 25, 2018

    DEKA MOTUS AX

    FDA Adverse Event
    Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·March 9, 2023

    DEKA MOTUS AX

    FDA Adverse Event
    Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·February 6, 2024

    CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025