BEUDAMED
    10,000 results · 35ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·METHAFILCON LENSES: FREQUENCY 55 TORIC, FREQUENCY XED TORIC XR, FREQUENCY 55 TONIC XR. METHAFILCON LENSES: HYDROSOFT XWP

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·ATTAIN STARFIX LEAD, 4195

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·PMS-600 PROGRAMMER

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    Agent, Absorbable Hemostatic, Non-Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·SURGICEL™ Original Absorbable Hemostat, SURGICEL™ NU-KNIT Absorbable Hemostat, SURGICEL™ Fibrillar Absorbable Hemostat,

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·PSW 2303.U, NEO 2303.U

    Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

    FDA Pre-Market Approval
    FDA Class 3 ·Sphere-9 Catheter and Affera Ablation System

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS MODELS T505/T510

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Adapta, Versa, Sensia IPG, Relia IPG

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P

    Intracranial Coil-Assist Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Siello S45, S53, S60 and Solia S45, S53, S60

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CareLink SmartSync Azure Astra Application

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Natural Eyes HydraWear™ XW Multifocal

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·ATTAIN STARFIX LEAD

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS