Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UV-ABSORBING ONE-PIECE PMMA ANTERIOR CHAMBER IOL

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·SYNVISC & SYNVISC-ONE (HYLAN G-F 20)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS ONE PIECE SOFT ACRYLIC INTRAOCULAR LENS (IOL)

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MynxGrip Vascular Closure Device, Mynx Control Vascular Closure Device (VCD)

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·DAKOCYTOMATION HERCEP TEST

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

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK VISION RX ZETA CORONARY STENT SYSTEMS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VOYAGER RX CORONARY DILATATION CATHETER

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK VISION RX FAMILY OF CORONARY STENT SYSTEMS