BEUDAMED
    15 results · 30ms · Sources: EU EUDAMED, US FDA

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    Emprint Ablation Visualization Application

    FDA 510(k)
    FDA Class 2 ·Radiology

    STRONG DENTAL HANDPIECES

    FDA 510(k)
    FDA Class 1 ·Dental

    HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 21, 2023

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·October 12, 2023

    T:SLIM G4 SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OYC·September 7, 2017

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·September 3, 2021

    HEARTSTART XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 4, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

    RESTORE RECHARGABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·September 29, 2008

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·August 20, 2021

    TRUEMETRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·October 25, 2017

    DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·January 9, 2013

    CHROMID® CARBA SMART

    FDA Adverse Event
    Malfunction ·BIOMERIEUX S.A.·Product code JSO·August 23, 2018

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 4, 2014