BEUDAMED
    11 results · 24ms · Sources: EU EUDAMED, US FDA

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    AMX-III

    FDA 510(k)
    FDA Class 2 ·Radiology

    KETAC-CEM IN REF. TO K802048

    FDA 510(k)
    FDA Class 2 ·Dental

    SECURACATH CATHETER, MODEL SPK01

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT2B27(CARDIOLOGY), PT3B27(CLASSIC), PT5B2

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COMBI-SET NON-MACHINE SPEC 8MM NO DC

    FDA Adverse Event
    Injury ·ERIKA DE REYNOSA·Product code FJK·January 21, 1999

    SECNDRY SET 34IN NDEHP

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code FPA·February 4, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·October 23, 2012

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code MMI·August 16, 2010

    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

    smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024