Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Obalon Balloon Kit

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Valiant Thoracic Stent Graft with the Captiva Delivery System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System

System, Identification, Contact Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTMARK

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DANKER SILICONE LENS (DIMEFOCON-A)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DANKER SILICONE LENS (DIMEFOCON-A)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CUSTOMEYES(TM) 45L&55L (BUFILCON A)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CUSTOMEYES(TM) 45L&55L (BUFILCON A)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DANKER SILICONE LENS (DIMEFOCON-A)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CSI CONTACT LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CSI(CROFILCON A)EXTENDED WEAR SOFT

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DANKER SILICONE LENS (DIMEFOCON-A)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DURASOFT4 (OFILCON A) CONTACT LENSES/SHELF LIFE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·8IGNATURE CONTACT LENS

System, Identification, Contact Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTMARK

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CUSTOMEYES 70L & 79L (LIDOFILCON A&B)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CIBATINT(TM) TINTING PROCESS