BEUDAMED
    119 results · 31ms · Sources: EU EUDAMED, US FDA

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    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·cobas EGFR MUTATION TEST v2

    COBAS® EGFR MUTATION TEST V2 P150044

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code OWD·April 1, 2026

    COBAS® EGFR MUTATION TEST V2 P150044

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code OWD·April 15, 2026

    COBAS® EGFR MUTATION TEST V2 P150044

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code OWD·March 27, 2025

    Oticon

    FDA UDI
    Oticon A/S·05707131285423·NERA2 PRO, MINIRITE 312 WL SGR

    TMA - Archwire

    FDA UDI
    ORMCO CORPORATION·00889989029581·TMA REV.CURVE/LOOPS 019X025 36MM PK/5

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180186880·METZ. SCISSORS, SINGLE ACTION, FLEXIBLE-INSULAT...

    Trial Cage 12deg 14L

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215066536·

    Tibial Cutting Block : SIZE 7

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215056933·

    P150048

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code LWR·September 23, 2024

    P150048

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code LWR·September 26, 2025

    O-PEP

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    50CM IMPLANT LEAD KIT, SLIM TIP

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code PMP·December 10, 2018

    50CM IMPLANT LEAD KIT, SLIM TIP

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code PMP·December 10, 2018

    50CM IMPLANT LEAD KIT, SLIM TIP

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code PMP·December 10, 2018

    50CM IMPLANT LEAD KIT, SLIM TIP

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code PMP·August 31, 2018

    PROCLAIM¿ DRG IMPLANTABLE PULSE GENERATOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code PMP·August 5, 2019

    Drug-Eluting Sinus Stent

    FDA Pre-Market Approval
    FDA Class 3 ·PROPEL

    Absorbable Collagen Hemostatic Agent With Thrombin

    FDA Pre-Market Approval
    FDA Class 3 ·VITAGEL RT3 SUTGICAL HEMOSTAT

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 7, 2014