BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    Neodent Implant System – GM Line

    FDA 510(k)
    FDA Class 2 ·Dental

    PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit

    FDA 510(k)
    FDA Class 2 ·Neurology

    E-Z CLEAN BALL 5IN

    FDA Adverse Event
    Malfunction ·MEGADYNE MEDICAL PRODUCTS, INC.·Product code GEI·August 9, 2018

    NEOCIS GUIDANCE SYSTEM

    FDA Adverse Event
    Injury ·NEOCIS INC.·Product code PLV·September 13, 2019

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·October 15, 2014

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·June 17, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 24, 2011

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code KMW·May 19, 2024

    Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·April 27, 2016