Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THxID BRAF assay kit

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·HERCEP TEST

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THERASCREEN KRAS RGQ PCR KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS EGFR MUTATION TEST

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·HER2 FISH PHARMADX KIT

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·ONCOR(R) AMPLITECT(TM) HER/NEU(ERBB2)GENE AMPLIFI

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationFocus CDxBRCA

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscoelastic System, and DISCOVISC™ Ophthalmic Viscosurgic

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SM-1, CR-1, & GR-1 IOLS

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT/DUOVISC Ophthalmic Viscoelastic System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS B-13F (P-10) & B-1H (P-11)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IOL LENS MODEL GR1A

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT, DISCOCISC Ophthalmic Viscosurgical Device

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADARVISION 4000 EXCIMER LASER SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA ANTERIOR CHAMBER IOLS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·LASER WELDING REVERSE HAPTIC ASPECT RATIO

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA INTRAOCULAR LENSES (IOLS)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UV ABSORBING POST.CHAM.IOL