BEUDAMED
    19 results · 30ms · Sources: EU EUDAMED, US FDA

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    ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780180272·Integra® Jarit® Cooley Intracardiac Needle Hold...

    Punch

    FDA UDI
    ELLIQUENCE, LLC·00846338004187·

    BELIFU

    FDA Adverse Event
    Injury ·HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED·Product code GZJ·February 10, 2020

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970423·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970393·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970416·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970409·

    GMD UNIVERSAL URINARY INCONTINENCE SLING

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

    SMARTWIRE/SMARTMAP PRESSURE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYSTEM 6 SAGITTAL SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code KIJ·May 20, 2013

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·September 26, 2014

    UNKNOWN DEPUY TIBIAL INSERT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·June 1, 2011

    BD FACSCALIBUR¿

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·December 28, 2021

    ACCESS ACCUTNI REAGENT

    FDA Adverse Event
    Injury ·BECKMAN COULTER·Product code MMI·September 15, 2016

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    Various products which were contract sterilized.

    FDA Enforcement
    Class II ·Ongoing·Anewmed Corporation·November 6, 2019

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023