BEUDAMED
    134 results · 29ms · Sources: EU EUDAMED, US FDA

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

    FDA Pre-Market Approval
    FDA Class 2 ·ABBOTT HBE DIAGNOSTIC KIT

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

    FDA Pre-Market Approval
    FDA Class 2 ·ABBOTT HBE (RDNA) EIA TEST KIT

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

    FDA Pre-Market Approval
    FDA Class 2 ·HBE RIA DIAGNOSTIC KIT

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

    FDA Pre-Market Approval
    FDA Class 2 ·ABBOTT HBE DIAGNOSTIC KIT

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

    FDA Pre-Market Approval
    FDA Class 2 ·ABBOTT HBE (RDNA) EIA

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

    FDA Pre-Market Approval
    FDA Class 2 ·ABBOTT HBE DIAGNOSTIC KIT

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

    FDA Pre-Market Approval
    FDA Class 2 ·ABBOTT HBE (RDNA) EIA

    VENTURE™ Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00721902988950·PLATE 9790025 ANT CERV ASSY 25MM

    TRUMPF MEDICAL

    FDA UDI
    Baxter Medical Systems GmbH + Co. KG·00887761990340·Table top segment Carbon 450 V

    VENTURE™ Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000890018·PLATE 9790025 ANT CERV ASSY 25MM

    Trimline

    FDA UDI
    ORMCO CORPORATION·00889989050974·UPPER RIGHT FIRST MOLAR TRIMLINE BAND SIZE 25

    COUNTER CHECK, H001, H002, H003

    FDA 510(k)
    FDA Class 2 ·Hematology

    FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+ FEM PRC RT M/LT L SML+ FEM PRC LT M/RT L REG FEM PRC RT M/LT L REG FEM PRC LT M/RT L REG+ FEM PRC RT M/LT L REG+ FEM PRC LT M/RT L LGE FEM PRC RT M/LT L LGE FEM PRC LT M/RT L LGE+ FEM PRC RT M/LT L LGE+ " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·Alinity m HCV

    Stimulator, Invasive Bone Growth

    FDA Pre-Market Approval
    FDA Class 3 ·OsteoGenTM Implantable Bone Growth Stimulators

    LIGAMAX 5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·May 5, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 15, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·July 26, 2007

    ALINITY M RESP-4-PLEX AMP KIT

    FDA Adverse Event
    Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·February 24, 2025

    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·Alinity m HCV