BEUDAMED
    29 results · 32ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    STIMEL-03

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    N/A

    FDA UDI
    Tyber Medical, LLC·M695M1304240·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450315705·

    SAFIRE

    FDA 510(k)
    FDA Class 2 ·Radiology

    DANMEDICAL ANALYSIS SYSTEM, MODEL D-MAS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·September 21, 2013

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·August 27, 2013

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·September 26, 2013

    FIGHTER SURETRAK II UNIVERSAL TRACKER, LARGE PASSIVE

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·August 13, 2019

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 24, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·September 30, 2014

    OPTIVANTAGE WITH PEDESTAL

    FDA Adverse Event
    Injury ·LIEBEL-FLARSHEIM CO.·Product code IZQ·June 14, 2011

    LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·September 25, 2018

    VENTED AUTOFEED CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·June 11, 2014

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·October 30, 2017

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·February 9, 2018

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Injury ·COOK INC·Product code GEX·February 28, 2018

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·February 8, 2018

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Injury ·COOK INC·Product code GEX·April 25, 2018

    CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·July 24, 2013