BEUDAMED
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    ACCESS® 2 IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·January 13, 2012

    ACCESS® 2 IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·January 13, 2012

    Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202 Lithium-ion Battery Cable, JHI-204 Extensions Cable, JHI-201 Pedestal Cable

    FDA Recall
    Terminated ·Jarvik Heart Inc·Product code DSQ·October 15, 2018

    Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202 Lithium-ion Battery Cable, JHI-204 Extensions Cable, JHI-201 Pedestal Cable

    FDA Enforcement
    Class II ·Terminated·Jarvik Heart Inc·December 26, 2018

    CLINITEK STATUS+

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JHI·December 2, 2019

    CLINITEK STATUS+

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JHI·October 21, 2019

    Hydrate

    FDA UDI
    BRIVANT LIMITED·00816349011474·

    Flagship

    FDA UDI
    BRIVANT LIMITED·00816349010903·

    Rapidwire

    FDA UDI
    BRIVANT LIMITED·00816349011047·

    Excursion

    FDA UDI
    BRIVANT LIMITED·00816349011603·

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code DHA·January 7, 2012

    SABRE 180

    FDA Adverse Event
    Injury ·CONMED ELECTROSURGERY·Product code GEI·February 20, 2020

    Flagship HS

    FDA UDI
    BRIVANT LIMITED·00816349010989·

    Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HI-TORQUE WHISPER LS; HI-TORQUE WHISPER MS; HI-TORQUE WHISPER MS CS-J; HI-TORQUE WHISPER ES; HI-TORQUE WHISPER ES CS-J

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARDINAL HEALTH RAPID TEST HCG CASS. 30T

    FDA Adverse Event
    Injury ·Product code JHI·December 2, 2016

    ADVIA CENTAUR XP TOTAL HCG (THCG)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code JHI·November 8, 2016

    HENRY SCHEIN HCG URINE CASSETTE 25T

    FDA Adverse Event
    Malfunction ·Product code JHI·October 25, 2016

    CONSULT HCG DIPSTICK TEST 5000 25T

    FDA Adverse Event
    Malfunction ·Product code JHI·December 16, 2016

    CONSULT HCG DIPSTICK TEST 5000 25T

    FDA Adverse Event
    Malfunction ·Product code JHI·November 17, 2016