BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    DUET SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    DL950 Braemar Base

    FDA UDI
    BRAEMAR MANUFACTURING, LLC·B146DL95020·

    TPN REDO

    FDA Adverse Event
    Malfunction ·COOK, INC.·Product code FOZ·August 3, 2016

    DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FOSSA URETERAL STONE SWEEPER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NPT·February 19, 2026

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·April 16, 2013

    FREESTYLE

    FDA Adverse Event
    Malfunction ·Product code NBW·April 18, 2011

    COBAS 6000 E601 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CEM·June 17, 2008

    ARCTIC SUN 5000

    FDA Adverse Event
    Malfunction ·MEDIVANCE, INC. ¿ 1725056·Product code DWJ·June 27, 2019

    CardioMD III (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS)

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Company·July 27, 2022

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018