BEUDAMED
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    HUMI-FLOW, MODEL 6-850-00/ 01/02

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Atos Medical

    FDA UDI
    ATOS MEDICAL INC.·00817126020702·2010-053 Laryngectomy Pulmonary Kit with Standa...

    Atos Medical

    FDA UDI
    ATOS MEDICAL INC.·00817126020542·Custom Laryngectomy Pulmonary Kit 12/55 With Pr...

    neoWave C

    FDA UDI
    XENIX MEDICAL LLC·00818345023833·Cervical Inserter

    TiWAVE C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07320K0100030·Implant Inserter, Cervical

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K0100030·Implant Inserter, InTess C

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0100030·Tap, 4.5mm Cann, Chuckable

    Ocata Anterior Cervical System

    FDA UDI
    Kalitec Direct LLC·B07308K0100030·Caddie Lid, Plates and Screws

    MATIRA ANTERIOR CERVICAL SYSTEM

    FDA UDI
    Kalitec Direct LLC·B07307K0100030·Caddie, 4 Level Plates

    COMFORT

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 23, 2026

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0100230·SNII Awl Tap, 7.50mm

    Matira

    FDA UDI
    Kalitec Direct LLC·B07307K0100230·Assembly, Caddie, 4L Plates, Hinged

    ACL 9000 SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Qualitative And Quantitative Hepatitis B Virus Antibody Assays

    FDA Pre-Market Approval
    FDA Class 2 ·IMMULITE 2000 XPI ANTI-HBC IMG

    SEE H10

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·IMMULITE 2000 Anti HBc IgM

    FDA Pre-Market Approval
    IMMULITE® 2000 Anti-HBc IgM

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·IMMULITE, IMMULITE 1000 ANTI-HBC AND IMMULITE 2000 ANTI-HBC