BEUDAMED
    41 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)

    FDA Enforcement
    Class II ·Terminated·Conformis, Inc.·June 19, 2019

    Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)

    FDA Enforcement
    Class II ·Terminated·Conformis, Inc.·June 19, 2019

    VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·January 1, 2014

    VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·January 31, 2024

    K-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine.

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·August 21, 2019

    K-Wire HBS Sterile Lot, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·August 21, 2019

    The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The Bio-Rad MONOLISA Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection.

    FDA Enforcement
    Class II ·Terminated·Bio-Rad Laboratories·September 26, 2012

    VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibrator tube (1 per level: C1 - green, C2 - yellow, C3 - red).

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·June 19, 2024

    iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right

    FDA Enforcement
    Class II ·Terminated·Conformis, Inc.·October 16, 2019

    iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right

    FDA Enforcement
    Class II ·Terminated·Conformis, Inc.·October 16, 2019

    ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.

    FDA Enforcement
    Class II ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025

    Go-EZ Screw 6.5x90, Item Number 19666 - Product Usage:Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·August 21, 2019

    Go-EZ Screw 6.5x110, Item Number 19670 - Product Usage:Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·August 21, 2019

    Go-EZ Screw 6.5x115, Item Number 19671 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·August 21, 2019

    Go-EZ Screw 6.5x38, Item Number 19655 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·August 21, 2019

    Go-EZ Screw 6.5x32, Item Number 19652 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·August 21, 2019

    K-Wire Sterile Single Trochar .045, Item Number 19108 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·August 21, 2019

    K-Wire Single Trocar 2.5x170mm, Item Number OL17025S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·August 21, 2019

    K-Wire Single Trocar 2.5x150mm, Item Number OL15025S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·August 21, 2019

    Go-EZ Screw 6.5x95, Item Number 19667 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·August 21, 2019