BEUDAMED
    50 results · 20ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Lens, Intraocular, Phakic

    FDA Pre-Market Approval
    FDA Class 3 ·STAAR SURGICAL IMPLANTABLE COLLAMER LENS (VISIAN ICL)

    Automated Insulin Dosing Device System, Single Hormonal Control

    FDA Pre-Market Approval
    FDA Class 3 ·Medtronic MiniMed Hybrid Closed Loop (HCL) 670G

    Lens, Intraocular, Phakic

    FDA Pre-Market Approval
    FDA Class 3 ·VISIAN ICL (IMPLANTABLE COLLAMER LENS) FOR MYOPIA

    Lens, Intraocular, Phakic

    FDA Pre-Market Approval
    FDA Class 3 ·STAAR SURGICAL IMPLANTABLE COLLAMER LENS (VISION ICL)

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart FR3 Primary Battery (989803150161)

    System, Laser, Photodynamic Therapy

    FDA Pre-Market Approval
    FDA Class 3 ·BLU -U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR

    Imager, Breast, Electrical Impedance

    FDA Pre-Market Approval
    FDA Class 3 ·T-SCAN 2000

    Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

    FDA Pre-Market Approval
    FDA Class 3 ·GENESEARCH BREAST LYMPH NODE ASSAY

    Imager, Breast, Electrical Impedance

    FDA Pre-Market Approval
    FDA Class 3 ·TS2000

    Kit, Test, In Vitro Periodontal

    FDA Pre-Market Approval
    FDA Class 3 ·PERIOCHECK TM ENZYME ACTIVITY TEST KIT

    Imager, Breast, Electrical Impedance

    FDA Pre-Market Approval
    FDA Class 3 ·TRANSCAN T-SCAN 2000

    Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

    FDA Pre-Market Approval
    FDA Class 3 ·GENESEARCH BREAST LYMPH NODE

    Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

    FDA Pre-Market Approval
    FDA Class 3 ·GENESEARCH BREAST LYMPH NODE (BLN) ASSAY

    Kit, Test, In Vitro Periodontal

    FDA Pre-Market Approval
    FDA Class 3 ·PERIOCHECK TM ENZYME ACTIVITY TEST KIT

    Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

    FDA Pre-Market Approval
    FDA Class 3 ·GENESEARCH BREAST LYMPH NODE(BLN) ASSAY

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·DEFLUX INJECTABLE GEL

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·PREVELLE SILK

    Organ Care System (Ocs) Heart System

    FDA Pre-Market Approval
    FDA Class 3 ·Organ Care System (OCS) Heart

    Organ Care System (Ocs) Heart System

    FDA Pre-Market Approval
    FDA Class 3 ·Organ Care System™ (OCS™) Heart

    Organ Care System (Ocs) Heart System

    FDA Pre-Market Approval
    FDA Class 3 ·OCS Heart System