BEUDAMED
    21 results · 28ms · Sources: EU EUDAMED, US FDA

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    VOCO PROFLUORID VARNISH

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743618·LEVAMED ANKLE SUPPORT SAND IV

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743731·ACHIMED ACHILLES SUPP SAND IV

    Azur Pure Helical

    FDA UDI
    Microvention, Inc.·00810170018251·Azur

    FINGER PULSE METER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AVISTA MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 8, 2023

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·November 23, 2016

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code CGA·July 27, 2016

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code NBW·September 28, 2016

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·December 13, 2016

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·October 26, 2016

    PULSE GEN MODEL 103

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·April 26, 2013

    TMJ SOLUTIONS

    FDA Adverse Event
    Injury ·TMJ CONCEPTS·Product code LZD·September 6, 2014

    AU681-02E CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER MISHIMA K.K.·Product code JJE·May 6, 2011

    Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO

    FDA Enforcement
    Class II ·Terminated·Clinical Innovations, LLC·February 4, 2015

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·January 16, 2017

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·July 26, 2016

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·September 12, 2016

    GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GlideScope Titanium System) consists of a sterile-packaged, single-use video laryngoscope, multi-use Smart Cable and portable GlideScope video monitor. The system incorporates a high-resolution, full-color digital camera and monitor for real-time viewing and recording. Affected Product Names and Part Numbers: -LoPro S3: 0574-0130 (single blade) or 0270-0769 (box of 10) -LoPro S4: 0574-0131 (single blade) or 0270-0770 (box of 10) -MAC S3: 0574-0132 (single blade) or 0270-0771 (box of 10) -MAC S4: 0574-0133 (single blade) or 0270-0772 (box of 10) The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures.

    FDA Enforcement
    Class I ·Terminated·Verathon, Inc.·March 16, 2016