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

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    CELERITY SYSYEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE

    FDA Adverse Event
    Malfunction ·COCHLEAR LTD·Product code MCM·April 17, 2019

    FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOMMED GENESIS PATIENT MONITOR SYSTEM WITH OPTIONS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 31, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 3, 2014

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·May 31, 2011

    FORTRESS INTRODUCER SHEATH SYSTEM - 6FR, 45CM

    FDA Adverse Event
    Malfunction ·CONTRACT MEDICAL INTERNATIONAL GMBH·Product code DYB·November 30, 2015

    A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting

    FDA Enforcement
    Class I ·Ongoing·Philips Respironics, Inc.·July 21, 2021

    C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·September 24, 2014

    Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013