10,000 results · 48ms · Sources: EU EUDAMED, US FDA

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval
FDA Class 3 ·ProCol Vascular Bioprosthesis

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·IPure Preloaded IOL System

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

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·ANCHORING SLEEVE KIT

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ENDEAVOR & ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING STENT SYSTEM

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·sentus QP LV Lead

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·Arctic Front Advance and Arctic Front Advance Pro

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·STAT S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval
FDA Class 3 ·INSPIRE II UPPER AIRWAY STIMULATOR

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

FDA Pre-Market Approval
FDA Class 3 ·VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·REBEL Platinum Chromium Coronary Stent System

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer™ Muscular VSD Occluder

System, Hemodynamic, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Cordella Pulmonary Artery Sensor System (CorPASS)

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·Minerva Endometrial Ablation System

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·AcrySof ReSTOR Posterior Chamber Intraocular Lenses

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval
FDA Class 3 ·Woven EndoBridge (WEB) Aneurysm Embolization System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Catheter, NaviStar RMT ThermoCool Catheter, NaviStar ThermoCool C

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·Svelte SLENDER® Sirolimus-Eluting Coronary Stent Integrated Delivery System (SLENDER IDS®), Svelte DIRECT Sirolimus-Elut

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

FDA Pre-Market Approval
FDA Class 3 ·TactiFlex™ Ablation Catheter, Sensor Enabled™