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

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    Kudu

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Bernafon

    FDA UDI
    Bernafon AG·05711584055441·SA5 ITC, L BE SAPHIRA 5

    ProLift Trial

    FDA UDI
    Life Spine, Inc.·00190837088248·

    HNM MEDICAL

    FDA UDI
    HNM STAINLESS, LLC.·00842962162231·ETHOS PRO ANGLED GUIDE

    AESKULISA ASCA A

    FDA 510(k)
    FDA Class 2 ·Immunology

    8 CHANNEL CARDIAC PHASED ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 12, 2025

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 8, 2014

    FLEXTEND

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 6, 2011

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code MLM·June 7, 2013

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023