BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    INFINION CX

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 28, 2020

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 9, 2021

    EMIT 2000 GENTAMICIN PLUS ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    LIGASURE ATLAS HANDSWITCHING 37CM

    FDA Adverse Event
    Malfunction ·COVIDIEN LLC (SHANGHAI)·Product code GEI·April 1, 2013

    CBC II-(1/8" KIT) PKG/6 WORLD

    FDA Adverse Event
    Injury ·STRYKER INSTRUMENTS PUERTO RICO·Product code CAC·April 19, 2011

    UNKNOWN ZIMMER TRILOGY LONGEVITY CONSTRAINED LINER

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code KWB·July 3, 2008

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022