BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

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    A&D Medical TM-2657 Family of Digital Blood Pressure Monitors

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SMDIA-1000

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EVERSTICK A&O

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 13, 2025

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE INC.·Product code LZG·October 6, 2014

    CARELINK

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code DXY·June 7, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

    CRIT-LINE BLOOD CHAMBER

    FDA Adverse Event
    Malfunction ·CONCORD MANUFACTURING·Product code KOC·July 21, 2018

    CATALYS SYSTEM

    FDA Adverse Event
    Injury ·AMO MANUFACTURING USA, LLC·Product code OOE·July 21, 2021

    Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 20, 2013

    Precise Treatment Table. To be used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 17, 2013

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014