BEUDAMED
    9 results · 25ms · Sources: EU EUDAMED, US FDA

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    SIMON NITINOL FILTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GOWNS, SURGICAL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MODIFIED GAS-STAT(TM) MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LOCKING TITANIUM ADAPTER

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·April 18, 2018

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 25, 2014

    INTEGRATED APD SET W/CASSETTE3-PRONG

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 10, 2010

    KC-002

    FDA Adverse Event
    Injury ·GENZYME BIOSURGERY·Product code GAO·June 13, 2008

    Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules intended for use in todays growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 14, 2013

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024