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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151111·Resolve® Ceramic R018 UL 5-5 CS BC HK

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151811·Resolve® Ceramic M018 UL 5-5 CS BC HK

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151121·Resolve® Ceramic R018 UL 5-5 CS HK/MBT 4-5

    Digimamo D

    FDA 510(k)
    FDA Class 2 ·Radiology

    RAP-PAC

    FDA UDI
    Smith & Nephew, Inc.·00885554011357·RAP PAC LTX

    Perfect Fit

    FDA UDI
    DYMEDIX DIAGNOSTICS, INC.·00817377021930·Interface Cable, Fast Track, Abdomen

    MYSTIQUE® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K110151101·MYSTIQUE® MB RT RX 018 U 5-5 CS HK

    NEBULAE I

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

    COBAS 6000 E 601 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·January 3, 2018

    COBAS E 411 IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·April 24, 2018

    LAS WORKCELL

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·October 20, 2008

    COULTER LH 750 HEMTOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·August 5, 2011

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013

    COBAS 8000 E 602 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code DHA·October 31, 2017

    1823260-2017-01845

    FDA Adverse Event
    Malfunction ·August 29, 2017

    COBAS 6000 E 601 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·December 6, 2017

    1823260-2017-02173

    FDA Adverse Event
    Malfunction ·October 3, 2017

    COBAS E 411 IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·February 2, 2018