BEUDAMED
    2,069 results · 69ms · Sources: EU EUDAMED, US FDA

    ORBIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

    Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5C

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Gold Standard Diagnostics, LLC·1 device

    HAILSTORM

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Gold Standard Diagnostics, LLC·1 device

    Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Gold Standard Diagnostics, LLC·1 device

    AIX1000 Analyzer

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Gold Standard Diagnostics, LLC·1 device

    Bolt

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Gold Standard Diagnostics, LLC·1 device

    ThunderBolt EIA (CLIA)

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Gold Standard Diagnostics, LLC·1 device

    Bolt (CLIA)

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Gold Standard Diagnostics, LLC·1 device

    ThunderBolt EIA

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Gold Standard Diagnostics, LLC·1 device

    Microtiterplates

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Gold Standard Diagnostics, LLC·1 device

    Gold Standard Diagnostics RPR Reagent Pack

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Gold Standard Diagnostics, LLC·1 device

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

    Lunar iDXA

    FDA UDI
    GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC·00840682117029·

    Venue

    FDA UDI
    GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC·00195278005830·Venue R3 MD eDelivery or Physical Upgrade

    Venue

    FDA UDI
    GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC·00195278516480·Venue R4 final Assembly

    Prodigy

    FDA UDI
    GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC·00840682138352·

    Venue

    FDA UDI
    GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC·00840682190510·Venue R3 final Assembly