BEUDAMED
    55 results · 34ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Oncomine Dx Target Test

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·ACRYSOF IQ TORIC IOLS

    System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

    FDA Pre-Market Approval
    FDA Class 3 ·TARGIS (T3) SYSTEM

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·RITHRON-XR CORONARY STENT SYSTEM

    Mr-Guided Focused Ultrasound System

    FDA Pre-Market Approval
    FDA Class 3 ·EXABLATE

    Mr-Guided Focused Ultrasound System

    FDA Pre-Market Approval
    FDA Class 3 ·Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·LADARVISION 4000 EXCIMER LASER SYSTEM

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Oncomine Dx Target Test

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)

    System, Oxygen, Aqueous

    FDA Pre-Market Approval
    FDA Class 3 ·TherOx DownStream System

    System, Oxygen, Aqueous

    FDA Pre-Market Approval
    FDA Class 3 ·TherOx Downstream System

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·CORDIS PRECISE NITINOL STENT SYSTEM

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE

    Extended Depth Of Focus Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·IC-8 Apthera Intraocular Lens (IOL)

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS

    Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

    FDA Pre-Market Approval
    FDA Class 3 ·FLEXATOME CUTTING BALLOON

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·CGuard Prime Carotid Stent System

    Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

    FDA Pre-Market Approval
    FDA Class 3 ·WOLVERINE CORONARY CUTTING BALLOON (MONORAIL & OVER-THE-WIRE)

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·STAR S4 IR EXCIMER LASER SYSTEM & WAVESCAN SYSTEM