BEUDAMED
    31 results · 22ms · Sources: EU EUDAMED, US FDA

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    PROFEMUR Z REVISION HIP STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772813148·GENUMEDI PRO SILVER SIZE I

    SoloPace Fusion Sterile Pack

    FDA UDI
    SOLO PACE INC.·00850056280044·

    Vatech Clismile

    FDA UDI
    Rayence Co., Ltd.·08800018601334·This product is an orthodontic bracket and is u...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450666456·

    Critical Cover

    FDA UDI
    Alpha Pro Tech, Inc.·10817583021615·Frock, GenPro, White, Raglan Sleeve, Elastic Wr...

    Sterile Sphincterotome

    FDA UDI
    Micro-Tech (Nanjing) Co., Ltd.·06932503513166·Sterile Sphincterotome, lumen 3, TIP length 5, ...

    O&P CRANICAL MOLDING HELMET

    FDA 510(k)
    FDA Class 2 ·Neurology

    JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·March 25, 2022

    TENDRIL SDX

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code DTB·January 13, 2014

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    UNKNOWN·Product code ITJ·May 20, 2013

    ADAPTER SLEEVE 12/14 +5

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 1, 2011

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·April 30, 2014

    BD PHASEAL OPTIMA INJECTOR (N35-O)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·August 2, 2019

    BD PHASEAL¿ OPTIMA SYSTEM, INJECTOR, N35-O

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·August 5, 2019

    Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON Auto: ICONAAN, ICONAAN-HT, ICONAAJ. ICON Novo: ICONNAN, ICONNAN-HT, ICONNAJ. ICON Premo: ICONPBN, ICONPBN-HT, ICONPBN-HTC. The ICON CPAP unit is for use on adult patients for the treatment of Obstructive Sleep Apnea (OSA). The device is for use in the home or sleep laboratory. The device is not intended to be used as a life supporting device.

    FDA Enforcement
    Class II ·Terminated·Fisher & Paykel Healthcare, Ltd.·June 5, 2013

    OPTIFLOW NASAL CANNULA

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code CAT·April 20, 2015

    CONNECTOR C35-O

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·April 30, 2021

    BD PHASEAL¿ OPTIMA CONNECTOR (C35-O)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·October 14, 2021