Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Epic Plus, Epic Max Tissue Heart Valves

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Conformable GORE® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent - Microfibrillar Form

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra AV Transcatheter Pacing System, Micra Transcatheter Pacing System, Micra VR Transcatheter Pacing System

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·Infuse Bone Graft/medtronic Interbody Fusion Devise

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·CoreValve EnVeo Pro Delivery Catheter System, CoreValve EnVeo Pro Loading System, Evolut PRO+ Delivery Catheter System,

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, CoreValve EnVeo R Delivery Catheter

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, IN.PACT 018 Paclitaxel-Coated

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Onyx Over The Wire Zotarolimus-Eluting Coronary Stent System, Resolute Onyx Frontier Rapid Exchange Zotarolimus

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

FDA Pre-Market Approval

FDA Class 3 ·DiamondTemp Catheter, Unidirectional, Small Curve, DiamondTemp Catheter, Unidirectional, Large Curve, DiamondTemp Cathet

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent - Fibrillar Form

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·Infuse Bone Graft

Agent, Occluding, Vascular, Permanent

FDA Pre-Market Approval

FDA Class 3 ·Venaseal Closure System

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS BIOSPROSTHETIC PULMONIC VALVED CONDUIT

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

FDA Pre-Market Approval

FDA Class 3 ·FLAIR ENDOVASCULAR STENT GRAFT

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·Solesta Injectable Gel

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DEFLUX Injectable Gel