System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·RelayPlus Thoracic Stent-Graft System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNX ACE VASCULAR CLOSURE DEVICE (MYNX ACE)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON) BRAND LENSES

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNXGRIP VASCULAR CLOSURE DEVICES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination

FDA Pre-Market Approval

FDA Class 3 ·LAMICEL OSMOTIC CERVICAL DILATOR

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 (senofilcon A) Brand Contact Lenses

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·ACUVUE (ETAFILCON A) CONTACT LENS

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNX VASCULAR CLOSURE DEVICE

System, Esophageal Pacing

FDA Pre-Market Approval

FDA Class 3 ·ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR SYSTEM

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·PyloPlus UBT System

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·S.M.A.R.T. CONTROL NITINOL STENT SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNX VASCULAR CLOSURE DEVICE

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 (ETAFILCON A)