BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    TOTAL SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Pointe Scientific, Inc.

    FDA UDI
    HORIBA INSTRUMENTS INCORPORATED·00811727013309·Testosterone for the quantitative determination...

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08800089466924·

    KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER-

    FDA 510(k)
    FDA Class 1 ·General Hospital

    UREA NITROGEN (BUN) LIQUID REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·May 6, 2013

    ILAB ULTRASOUND IMAGING SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - FREMONT (CE)·Product code OBJ·September 23, 2014

    12/14 ARTICUL 40MM M SPEC+8.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 13, 2011

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code FCG·December 26, 2017

    ENDOSKELETON® TCS NO 6 SWIVEL DRIVER

    FDA Adverse Event
    Malfunction ·TITAN SPINE, LLC·Product code HXX·January 28, 2016

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021