BEUDAMED
    10 results · 27ms · Sources: EU EUDAMED, US FDA

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    OMS QUARTZ INFUSION CONTACT LENS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    INVIGRA

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

    PATIENT POSITIONING SYSTEM 1D OR 2D

    FDA 510(k)
    FDA Class 1 ·Radiology

    GX-770

    FDA Adverse Event
    Malfunction ·GENDEX DENTAL SYSTEMS·Product code EHD·May 1, 2014

    EMERGE¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·November 6, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 4, 2015

    CONCERTO NYLON

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·June 15, 2020

    INSYTE AUTOG BC GLOBAL BL 22GA X 1.0IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FOZ·December 5, 2023

    ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\ The ACCU-CHEK Combo System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code NBW·October 25, 2013

    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 2012