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

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    CoreLevee

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    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

    CANDELA SCLERO LONG PULSE LASER (AKA VBEAM)

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

    IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)

    FDA 510(k)
    FDA Class 2 ·Neurology

    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

    AVOSET INFUSION PUMP ROW

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

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0°

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·July 5, 2023

    COBAS 6000 C501 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code DAP·October 22, 2008

    COLLEAGUE CXE VOLUMETRICINFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 9, 2013

    BD ULTRA-FINE¿ MINI PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·January 5, 2022

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    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