Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval

FDA Class 3 ·LINX REFLUX MANAGEMENT SYSTEM

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SPF-4T IMPLANTABLE SPINAL FISION STIMULATOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DF-1 CONNECTOR PORT PIN PLUG,IS-1 CONNECTOR PORT PIN PLUG KIT,SPRINT QUATTRO LEAD,SUBCUTANEOUS LEAD,TRANSVENE CS/SVC LEA

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODIFIED J & C LOOP MODEL PA36

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ONE PIECE POSTERIOR CHAMBER IOL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL SI-11NB UV ABSORBING SILICONE POSTERIOR IOL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CT LUCIA Intraocular Lens (IOL)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CHAMBER LENS MODELS 101, 101B, 101T

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ANTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Lenstec Softec HD aspheric posterior chamber intraocular lens

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SILICONE AND PMMA INTRAOCULAR LENSES AND OCUCOAT

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·COLLAMER(TM) ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS 3-Piece Acrylic Monofocal

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CHAMBER LENS MODELS 101, 101B, 101T

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·C-flex lntraocular Lens, C-flex Aspheric lntraocular Lens, 6.0 mm Aspheric lntraocular Lens, and RayOne Aspheric

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF INTRAOCULAR LENSES (IOLS)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SM-1, CR-1, & GR-1 IOLS