Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·EnVista One Piece Hydrophobic Acrylic Intraocular Lens (IOL), Model MX60E Lens Holder

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof® IQ Aspheric IOL with the UltraSert Pre-Loaded Delivery System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ISERT GEMETRIC

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSES

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF IQ RESTOR +2.5 D MULTIFOCAL INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IOLAB BRAND MODEL 2192 KELMAN UVBLOC PLUS (LC) UV-ABSORBING PMMA AC IOLS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SENSAR & TECNIS ONE-PIECE ACRYLIC POSTERIOR CHAMBER IOLS (MODELS AAB00 & ZCB00)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ULTRAVIOLET (UV) ABSORBING AND NON-UV ABSORBING POLYMETHYLMETHACRYLATE (PMMA) POSTERIOR CHAMBER INTRAOCULAR LENSES (IOL)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Hoya AF-1 Case Lens Case Lens and ISert Pre-loaded IOL Injector Systems

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IOLAB BRAND MODEL U85J UVBLOC PLUS (LC) UV-ABSORBING ONE-PIECE FLEXIBLE AC IOLS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·VIDAS TOTAL PSA

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THxID BRAF assay kit