BEUDAMED
    28 results · 18ms · Sources: EU EUDAMED, US FDA

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    EXTENDED RANGE HS CRP KIT, CAT NO:9200

    FDA 510(k)
    FDA Class 2 ·Immunology

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA UDI
    FX SOLUTIONS·03701037309018·HUMELOCK REVERSED GLENOID MANUAL REAMER Ø40mm

    SOAR Retractor System

    FDA UDI
    SPINEOLOGY INC.·M7403030044·18mm Dilator

    SCFE Screw

    FDA UDI
    ORTHOPEDIATRICS CORP.·00841132114216·4.0mm X 44mm MED THREAD CANNULATED SCREW

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0100440·Assembly, Caddie, Locking Caps

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0100440·Caddie, Locking Caps

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710420300440·Anterio Lateral Closing Wedge Osteotomy Guide, ...

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710410300440·Anterior Closing Wedge Osteotomy Guide, 30mm x ...

    Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

    FDA Pre-Market Approval
    FDA Class 3 ·DAKOCYTOMATION EGFR PHARMDX

    ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINEWANDS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    COPELAND RESURFACING HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

    FDA Pre-Market Approval
    FDA Class 3 ·EGFR pharmDx

    Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

    FDA Pre-Market Approval
    FDA Class 3 ·EGFR pharmDx

    Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

    FDA Pre-Market Approval
    FDA Class 3 ·DAKO EGFR PHARMDX KIT

    Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

    FDA Pre-Market Approval
    FDA Class 3 ·EGFR pharmDx

    Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

    FDA Pre-Market Approval
    FDA Class 3 ·DAKOCYTOMATION EGFR PHARMDX KIT

    Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

    FDA Pre-Market Approval
    FDA Class 3 ·EGFR pharmDx

    Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

    FDA Pre-Market Approval
    FDA Class 3 ·EGFR pharmDx

    Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers: 01-03-0042 01-03-0044 01-03-0045 01-03-0047 01-03-0049 01-03-0051 01-03-0052

    FDA Enforcement
    Class II ·Ongoing·Synovo Production·April 17, 2024

    DRX-REVOLUTION

    FDA Adverse Event
    Malfunction ·CARESTREAM HEALTH, INC.·Product code IZL·March 28, 2013