BEUDAMED
    17 results · 30ms · Sources: EU EUDAMED, US FDA

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    FUKUDA DENSHI VASERA MODEL VS-1500

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Biosens cartridges Standard Pink Clear

    FDA UDI
    PERFLEX LTD·07290110501716·box of 6 identical cartridges sealed in aluminu...

    Disc Prep

    FDA UDI
    Life Spine, Inc.·00190837090050·

    BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    PANTINO PRO POSITINER

    FDA 510(k)
    FDA Class 2 ·Dental

    ECHI GREENVILLE NC 2

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·November 22, 2011

    ECHI GREENVILLE NC 2

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·November 30, 2011

    STONYBROOK HSP NY NY 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code OEZ·September 15, 2015

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·May 14, 2013

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·May 25, 2011

    LIFEPAK 20E DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·August 11, 2008

    C21785 IT TREVISO

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code GEI·December 14, 2012

    D731 MICRO 27 ARTERIAL FILTER WITH 27 MICRON PHISIO COATING

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTM·May 18, 2022

    D731 MICRO 27 ARTERIAL FILTER WITH 27 MICRON PHISIO COATING

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTM·March 17, 2022

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

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

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025