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

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    C-SPLINT

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Total Foot System 2

    FDA UDI
    Smith & Nephew, Inc.·00885556838136·INTERPOSITIONING PLATE. 4MM STEM

    Integra® Total Foot System

    FDA UDI
    Ascension Orthopedics, Inc.·10381780119463·The Integra Total Foot System interpositioning ...

    Needle Holder

    FDA UDI
    KATENA PRODUCTS, INC.·00841668118221·McPherson NdlHldr, X-Del, Cvd W/O Lock

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112731·BARRON VACUUM PUNCH 7.0MM

    ADAPTOR,1,P1802,(2)S1802

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828119139·ADAPTOR,1,P1802,(2)S1802

    COMBINED PHYSIOLOGICAL MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIFEPAK CR® PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·October 23, 2012

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 30, 2013

    ADULT NASAL INTERFACE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code CAT·August 17, 2010

    SURE-T PARADIGM

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 30, 2024

    ACTIVELIFE

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EZQ·November 7, 2019

    ACTIVELIFE

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EZQ·November 7, 2019

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·October 5, 2022

    SURE-T PARADIGM

    FDA Adverse Event
    Malfunction ·UNOMEDICAL UM-D·Product code FPA·February 21, 2025

    SURE-T PARADIGM

    FDA Adverse Event
    Malfunction ·UNOMEDICAL UM-D·Product code FPA·February 21, 2025

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024