BEUDAMED
    10,000 results · 51ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA

    Acid, Hyaluronic, Intraarticular

    FDA Pre-Market Approval
    FDA Class 3 ·HYMOVIS®

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·COBAS EGFR Mutation Test and cobas EGFR Mutation Test, v2.0

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Freezor, Arctic Front Advance (AFA) CryoAblation Catheters

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·Platinium CRT-D and Platinium 4LV CRT-D (Cardiac Resynchronization Therapy Defibrillator)

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

    FDA Pre-Market Approval
    FDA Class 3 ·AngioSculpt PTCA Scoring Balloon Catheter

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus ELITE Everolimus-Eluting Platinum Chro

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·External Paulse Generator (EPG) Patient Cable

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), leads, extensions, and accessories

    Stimulator, Electrical, Implantable, For Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·Axonics Sacral Neuromodulation System

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor kit, IS-1 COnnector Port Pin Plug Kit, Lead Ad

    Leadless Pacemaker

    FDA Pre-Market Approval
    FDA Class 3 ·Micra Transcatheter Pacing System

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·VERIFLEX (LIBERTE) CORONARY STENT SYSTEM

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·CEEON & TECNIS UV-ABORBING POSTERIOR CHAMBER INTRAOCULAR LENSES

    System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·MERLIN PATIENT CARE SYSTEM ACCESSORIES

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·RX ACCULINK CAROTID STENT SYSTEM