BEUDAMED
    23 results · 28ms · Sources: EU EUDAMED, US FDA

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    EXPRESSION INFORMATION PORTAL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TASMIN R 12°

    FDA UDI
    SIGNUS Medizintechnik GmbH·04047844014974·The basic shape of the TASMIN R devices is a ho...

    SafeGuide®

    FDA UDI
    DIVERSATEK HEALTHCARE, INC.·00816734021064·Esophageal Dilator, 24 French

    MaxFuse VBR, 10 (D) x 12 (W) x 45 (H)

    FDA UDI
    Pioneer Surgical Technology, Inc.·00846468055448·10 (D) x 12 (W) x 45 (H), 8 (L)

    VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PHARMACARIBE INHALED SALINE SOLUTIONS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    3004753838-2018-121424

    FDA Adverse Event
    Malfunction ·October 12, 2018

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 19, 2025

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 21, 2024

    Matrixx System

    FDA UDI
    NEXXT SPINE, LLC·00889929034323·Corpectomy, 12Dx14Wx24H 6°

    Matrixx System

    FDA UDI
    NEXXT SPINE, LLC·00889929034132·Corpectomy, 12Dx14Wx24H 0°

    Matrixx System

    FDA UDI
    NEXXT SPINE, LLC·00889929059487·Convexx Corpectomy, 12Dx14Wx24H, 6°

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·March 25, 2022

    ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code ORG·March 5, 2019

    ARTHREX ANGEL SYSTEM WITH ASPIRATION KIT

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code ORG·May 1, 2019

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    STRYKER CORP. - MEDICAL DIV.·Product code FPO·August 11, 2008

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·May 6, 2011

    THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code GWO·April 16, 2018

    NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.

    FDA Enforcement
    Class II ·Terminated·Nidek Inc·September 4, 2013