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

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    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

    Avoset Infusion Pump System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    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

    Arterys MICA

    FDA 510(k)
    FDA Class 2 ·Radiology

    QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE)

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

    CRE ESOPHAGEAL/PHYLORIC/COLONIC WIREGUIDED BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code KNQ·October 22, 2008

    COLLEAGUE

    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

    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

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021