Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, and Impella 5.5 with SmartAssist

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·IMPELLA 2.5 SYSTEM

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·IMPELLA CP with Smart Assist

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·iSert Preloaded IOL System, Intraocular Lens - Clarisert

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ISPHERIC MODEL YA-60BB INTRAOCULAR LENS

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·CRCDx RAS Mutation Detection Assay Kit

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·LIMULUS AMEBOCYTE LYSATE BACTERIA TEST

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·iSymm, iSpheric IOL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ISERT GEMETRIC MODEL 750 AND ISERT GEMETRIC MODEL 751 INTRAOCULAR LENS (IOL)

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

Telescope, Implantable, Miniature

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE (IMT)

Telescope, Implantable, Miniature

FDA Pre-Market Approval

FDA Class 3 ·Implantable Miniature Telescope

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ezSert Preloaded Delivery System

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·Glaukos iStent Trabecular Micro-Bypass Stent System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ISERT PY-60AD