BEUDAMED
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    JANUS G3 NGS Express

    FDA UDI
    Caliper Life Sciences, Inc.·00812589020603·JANUS G3 NGS Express, IVD

    Neocis Guidance System (NGS)

    FDA 510(k)
    FDA Class 2 ·Dental

    MammaPrint FFPE NGS Kit

    FDA 510(k)
    FDA Class 2 ·Immunology

    Mia Secret

    FDA UDI
    MIA SECRET·00842342116533·

    NGS TESTING

    FDA Adverse Event
    Injury ·GRANGER GENETICS·Product code NTR·December 5, 2016

    Bone Anchor (NGS-BA-01)

    FDA 510(k)
    FDA Class 2 ·Neurology

    EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE

    FDA Adverse Event
    Injury ·SHIRAKAWA OLYMPUS CO., LTD.·Product code PSV·September 26, 2024

    EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE

    FDA Adverse Event
    Injury ·SHIRAKAWA OLYMPUS CO., LTD.·Product code PSV·September 26, 2024

    GENESEEQPRIME NGS Tumor Profiling Assay (FFPE)

    FDA UDI
    Geneseeq Technology Inc·00860013470999·

    NGS-Turbo® demo workflow reagents

    FDA UDI
    GenBio·00613745003689·

    NEOCIS INC.

    FDA Adverse Event
    Injury ·NEOCIS INC.·Product code PLV·December 17, 2021

    Neocis Guidance System (NGS) with Patient Splints

    FDA 510(k)
    FDA Class 2 ·Dental

    Neocis Guidance System (NGS) with Chairside Splint

    FDA 510(k)
    FDA Class 2 ·Dental

    GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)

    FDA 510(k)
    FDA Class 2 ·Pathology

    LIFECODES HLA-A ERES SSO TYPING KIT

    FDA Adverse Event
    Malfunction ·IMMUCOR GTI DIAGNOSTICS, INC.·Product code MZI·December 16, 2020

    COBAS® EGFR MUTATION TEST V2

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code OWD·September 19, 2024

    KIT BD MAX CHECK-POINTS CPO IVD

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code POC·February 23, 2023

    ClearPoint

    FDA UDI
    Clearpoint Neuro, Inc.·00850359007805·Bladed Lancet

    SmartFrame

    FDA UDI
    Clearpoint Neuro, Inc.·00850359007850·SmartFrame XG Exchangeable Device Guide, 2.5-mm

    SmartFrame

    FDA UDI
    Clearpoint Neuro, Inc.·00850359007256·SMARTFrame Guide Tubes .060” / 17 ga