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

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    More-Cell-System

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Bernafon

    FDA UDI
    Bernafon AG·05711584114377·AN3, BTE UP 2.4G NFM SABE ALTENA 3 GPL

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704514421·HANK DILATORS 6/SET

    VDRIVE W/V-SONO

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SURGICAL RETRACTORS

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

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·April 10, 2023

    FLEXTEND IS-1 BI POSITIVE FIX

    FDA Adverse Event
    Death ·GUIDANT PACEMAKERS, INC., GUIDANT PUERTO RICO B.V.·Product code DTB·October 24, 2008

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·August 11, 2011

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code LWS·July 9, 2013

    HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.

    FDA Enforcement
    Class II ·Terminated·HemoCue AB·September 18, 2013