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

FDA Pre-Market Approval

FDA Class 3 ·HER2 IQFISH PHARMDX

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

FDA Pre-Market Approval

FDA Class 3 ·PathVysion HER-2 DNA Probe Kit

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

FDA Pre-Market Approval

FDA Class 3 ·PATH VYSION HER-2 DNA PROBE KIT ASSAY

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

FDA Pre-Market Approval

FDA Class 3 ·VYSIS PATH VYSION HER-2 DNA PROBE KIT

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

FDA Pre-Market Approval

FDA Class 3 ·HER2 IQFISH PHARMDX

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

FDA Pre-Market Approval

FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

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

FDA Pre-Market Approval

FDA Class 3 ·HER2 FISH PHARMDX KIT

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

FDA Pre-Market Approval

FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

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

FDA Pre-Market Approval

FDA Class 3 ·Path Vysion HER-2 DNA Probe Kit

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·Healon EndoCoat® Ophthalmic Viscosurgical Device (OVD) (3% Sodium Hyaluronate)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVOCES (OVD), HEALON GV, HEALON5 PRODUCTS

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·BVI 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·BD 1% OVD ( 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM, JEWEL, MICRO JEWEL, JEWEL PLUS, MICRO JEWEL II PCD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM,JEWEL,MOCRO JEWEL,JEWEL PLUS,MICRO JEWEL II,PCD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM, JEWEL, MICRO JEWEL, JEWEL PLUS, MICRO JEWEL II, PCD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM, JEWEL, MICRO JEWEL, JEWEL PLUS, MICRO JEWEL II, PCD

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·Amvisc Ophthalmic Viscosurgical Device, Amvisc Plus Ophthalmic Viscosurgical Device (OVD)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·BD 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·BVI 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)