Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Portico™ Transcatheter Aortic Heart Valve

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·enVista One-Piece Hydrophobic Acrylic Toric Intraoculer Lens (IOL)

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Mobi-C® Cervical Disc Prosthesis (one-level use)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·enVista One Piece Hydrophobic Acrylic Intraocular Lens Vial Manufacturing

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·LDR Spine Mobi-C Cervical Disc Prosthesis (One Level)

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·LDR Spine Mobi-C Cervical Disc Prosthesis (One Level)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·iSert Preloaded Posterior Chamber One-Piece Intraocular Lens (IOL)

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Prospera SCS System, Resilience Percutaneous Lead, Embrace One, TrueLock

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Prospera SCS System, Resilience Percutaneous Lead, Embrace One, TrueLock

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·EN VISTA ONE PEICE HYDROPHOBIC ACRYLIC LENS, MODEL MX60

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Prospera SCS System, Resilience Percutaneous Lead, Embrace One, TrueLock

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·TRANSCEND HIP ARTICULATION SYSTEM

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Oncomine Dx Target Test

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval

FDA Class 3 ·enVista One-Piece Hydrophobic Acrylic Toric Intraocular Lens (Model MX60T)

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·LDR SPINE MOBI-C CERVICAL DISC PROTHESIS (ONE LEVEL INDICATION)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ZENITH AAA ENDOVASCULAR GRAFT WITH H&L ONE SHOT INTRODUCTION SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL 3

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITALITY

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·Aptima HPV Assay

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·EluNIR Ridaforolimus Eluting Coronary Stent System