BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro

    FDA 510(k)
    FDA Class 2 ·Neurology

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111308093·SKLARLTE XD HALSEY NH SM 5"

    IMDX C.DIFFICILE FOR ABBOTT M2000

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 24, 2024

    GLIDEWELL HT IMPLANT Ø4.3 X 13 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 25, 2025

    GLIDEWELL HT IMPLANT Ø4.3 X 13 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·September 18, 2025

    GLIDEWELL HT IMPLANT Ø4.3 X 13 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 25, 2025

    DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 11, 2024

    ALINITY I HBSAG QUALITATIVE II REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·August 8, 2024

    ALINITY I HBSAG QUALITATIVE II CONFIRMATORY REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·August 8, 2024

    UNKNOWN DEPUY ASR HEAD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KXA·August 18, 2011

    LAP-BAND ADUSTABLE GASTRIC BANDING SYSTEM

    FDA Adverse Event
    Injury ·COSTA RICA·Product code LTI·November 13, 2008

    ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL·Product code FZP·July 8, 2013

    GLIDEWELL HT IMPLANT Ø4.3 X 13 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·June 4, 2025

    Niobe ES System, Models 001-006000-1 and 001-006100-1

    FDA Enforcement
    Class II ·Terminated·Stereotaxis Inc·November 18, 2020

    Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images.

    FDA Enforcement
    Class II ·Terminated·Carestream Health, Inc.·November 6, 2013

    Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 --- The DRX Revolution Mobile system is a mobile diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are mobile diagnostic x-ray systems designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.

    FDA Enforcement
    Class II ·Terminated·Carestream Health Inc.·January 15, 2014