BEUDAMED
    14 results · 19ms · Sources: EU EUDAMED, US FDA

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    ACA TRICYCLIC ANTIDEPRESSANTS SCREEN

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    NeurAxis IB-Stim (01-1020)

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

    SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·July 3, 2017

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·June 30, 2020

    PENUMBRA COIL 400

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·May 30, 2014

    ASR ACETABULAR CUPS 50

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·November 21, 2012

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·September 17, 2010

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·November 23, 2017

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·January 8, 2018

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·October 1, 2019

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP 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

    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

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024