BEUDAMED
    16 results · 26ms · Sources: EU EUDAMED, US FDA

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    TOMTEC-ARENA

    FDA 510(k)
    FDA Class 2 ·Radiology

    AVOSET INFUSION PUMP ROW

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·March 25, 2025

    AVOSET INFUSION PUMP ROW

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·March 25, 2025

    ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER

    FDA 510(k)
    FDA Class 2 ·Neurology

    SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096

    FDA 510(k)
    FDA Class 2 ·Hematology

    AVOSET INFUSION PUMP ROW

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·March 25, 2025

    AVOSET INFUSION PUMP ROW

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·June 22, 2025

    AVOSET INFUSION PUMP ROW

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·December 23, 2025

    AVOSET INFUSION PUMP ROW

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·January 5, 2026

    AVOSET INFUSION PUMP ROW

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·January 5, 2026

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 6, 2025

    AVOSET INFUSION PUMP ROW

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·April 29, 2026

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·August 16, 2011

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code JTC·August 1, 2008

    VITALITY

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017