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

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    VARIOUS ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Neurology

    HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·December 23, 2010

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 17, 2014

    SYSTEM 6 ASEPTIC HOUSING ASSY

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·December 21, 2012

    T5-NT, Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·April 25, 2018

    T5 Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·April 25, 2018

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024