10,000 results · 456ms · Sources: EU EUDAMED, US FDA

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Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR

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

FDA Pre-Market Approval
FDA Class 3 ·SelectSecure Lead

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·PROVISC™ Ophthalmic Viscosurgical Device

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Gore Excluder Conformable AAA Endoprosthesis (CEXC)

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) REBBIT MONOCLONAL PRIMARY ANTIBODY

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

FDA Pre-Market Approval
FDA Class 3 ·PROLIEVE THERMODILITATION SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·CapSure SP Novus Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·GEL-ONE

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Freestyle Bioprosthesis, Models 995, 995CS and 995MS

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval
FDA Class 3 ·Mentor Saline-Filled and Spectrum Breast Implants

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SPRINT QUATTRO/SUBCUTANEOUS LEAD

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

FDA Pre-Market Approval
FDA Class 3 ·CapSure Epicardial Pacing Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·INGENIO,ADVANTIO,VITALIO,FORMIO IMPLANTABLE PULSE GENERATORS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·Arctic Front Advance, Arctic Front Advance Pro™ Cardiac Cryoablation Catheter and Manual Retraction Kit

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·COGNIS/INCEPTA/ENERGEN/PUNCTUA/LIVIAN CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·ATTAIN

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATOR

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·Master InterStim® Therapy System

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·MemoryGel Silicone Gel-Filled Breast Implants

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval
FDA Class 3 ·ARTEGRAFT COLLAGEN VASCULAR GRAFT