BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    COURIER II

    FDA 510(k)
    FDA Class 1 ·Radiology

    ZAVATION

    FDA UDI
    Zavation LLC·00842166117075·Polyaxial Screw 3.5mm x 14mm

    Premium Plus C01/C02 LED Curing Light

    FDA 510(k)
    FDA Class 2 ·Dental

    TRIATHLON TOTAL KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SQUARE SCREWDRIVER

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·November 26, 2019

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code OJX·February 9, 2013

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·LIVANOVA USA, INC.·Product code LYJ·January 5, 2011

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - CALI·Product code KDI·July 23, 2014

    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