BEUDAMED
    10 results · 26ms · Sources: EU EUDAMED, US FDA

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    SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    POWERTONE, MODEL PT-11

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    AxSOS 3 Ti; Stryker Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 10, 2014

    PULSE GEN MODEL UNK

    FDA Adverse Event
    Injury ·CYBERONICS INC·Product code LYJ·December 10, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·June 23, 2015

    SULOX, HEAD, M, 32/0, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·September 15, 2017

    TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 453564007281, 989803196951

    FDA Recall
    Terminated ·Philips North America, LLC·Product code MHX·March 5, 2020

    TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 453564007281, 989803196951

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·February 3, 2021

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021