BEUDAMED
    15 results · 22ms · Sources: EU EUDAMED, US FDA

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    PuriLens Plus Preservative Free Saline

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    AMSCO CENTURY MEDIUM STERILIZER 26 X 26

    FDA 510(k)
    FDA Class 2 ·General Hospital

    UNIVEC TWO PIECE SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FUSION QUATTRO EXTRACTION BALLOON

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code GCA·December 10, 2024

    AUVON TENS & EMS DEVICE

    FDA Adverse Event
    Injury ·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·January 28, 2025

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008

    ECHELON*FLEX45 ARTICULATING

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 11, 2011

    MINICAP TRANSFER SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 1, 2013

    AUVON TENS UNIT

    FDA Adverse Event
    Injury ·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·December 19, 2024

    UNK CERAMIC HEAD

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code KWA·April 26, 2021

    UNK SHP ARCOM ACETABULAR CUP

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code KWA·April 26, 2021

    UNK STANMORE STEM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDI·April 26, 2021

    FUSION QUATTRO EXTRACTION BALLOON

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code GCA·June 7, 2024

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021