BEUDAMED
    23 results · 33ms · Sources: EU EUDAMED, US FDA

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    LZI Fentanyl II Enzyme Immunoassay

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DJO SURGICAL

    FDA UDI
    Encore Medical, L.P.·00190446929857·SPECIAL, TAPERFILL BIPOLAR TRIALS, +8mm, SM

    Conventional Lead Apron .5mm Large 24 X 42

    FDA UDI
    Flow X Ray Corporation·00843696123536·Conventional Lead Apron .5mm Large 24 X 42, Shi...

    VITALCARE URETHRAL CATHETER

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

    VECTOR TARGETING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM SHARE SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·January 8, 2016

    HF SENSOR DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC. - CARDIOMEMS·Product code MOM·March 14, 2018

    PROMUS PREMIER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·July 23, 2019

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM SHARE SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 25, 2015

    IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·March 23, 2020

    DESARA

    FDA Adverse Event
    Injury ·CALDERA MEDICAL, INC.·Product code OTN·October 20, 2014

    EMPI

    FDA Adverse Event
    Malfunction ·EMPI·Product code EGJ·August 5, 2011

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 4, 2015

    THERAPY¿ ABLATION CATHETER

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC.·Product code OAD·August 23, 2019

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·March 7, 2018

    ECHELON ENDOPATH STAPLER

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 15, 2020

    MEDTRONIC NAVIGATION

    FDA Adverse Event
    Death ·MEDTRONIC NAVIGATION, INC·Product code HAW·May 8, 2023

    COREVALVE TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·January 10, 2020

    PROMUS PREMIER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·August 1, 2019

    ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2 REUSABLE, ATAR-MDT2S-A, DK BLUE 30CM REUSABLE, ATAR-MDT2S-V WHITE 30CM REUSABLE, ATAR-MDTL REUSABLE, ATAR-MDTR REUSABLE, ATAR-R REUSABLE, ATAR-R T4P REUSABLE, ATAR-R1 REUSABLE, ATAR-RL REUSABLE, ATAR-T REUSABLE, ATAR-V WHITE REUSABLE, ATAR-V2 REUSABLE, XI.A DARK BLUE REUSABLE, XI.MDT REUSABLE, XI.R REUSABLE, XI.V WHITE, REUSEABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker

    FDA Enforcement
    Class I ·Terminated·Oscor, Inc.·July 19, 2017