Device, Hemostasis, Vascular

FDA Pre-Market Approval

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

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IOL DELIVERY SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNX VASCULAR CLOSURE DEVICE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) W/UV BLOCKER

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNX CADENCE VASCULAR CLOSURE DEVICE

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNXGRIP VASCULAR CLOSURE DEVICE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (ETAFILCON A) CONTACT LENSES

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO(R) II SAVVI(TM) PACING SYS MODEL 325 & 333

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·CCS MODEL 333 PACEMAKER INTRO. 3 NEW MODELS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·INCRAFT(R) AAA STENT GRAFT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) BRAND CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) BRAND CONTACT LENSES

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO SERIES 500 P.G.& MODEL 1006 PACEMAKER PROG

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·THE SOFTEC HD IOL

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Cordis® S.M.A.R.T.® CONTROL® Nitinol Stent Systems, Cordis® S.M.A.R.T.® and S.M.A.R.T.® CONTROL® Vascular Stent Systems

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL PA48A-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·HQL Softec HD, Softec I, Softec HD PS, Softec HDO, Softec HDM

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

FDA Pre-Market Approval

FDA Class 3 ·EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM