Stent, Iliac Vein

FDA Pre-Market Approval

FDA Class 3 ·Zilver Vena® Venous Self-Expanding Stent

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·samaritan Public Access Automated External Defibrillators and Accessories

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·AcrySof ReSTOR IOLs

Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

FDA Pre-Market Approval

FDA Class 3 ·T-SPOT.TB TEST

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF INTRAOCULAR LENSES

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·samaritan® PAD 350P (SAM 350P), samaritan® PAD 360P (SAM 360P), samaritan® PAD 450P (SAM 450P), Pad-Paks (Adult, Pediatr

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·SUNLIGHT OMNISENSE BONE SONOMETER

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·BioMimics 3D Vascular Stent System

Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·samaritan 350P (SAM350P) Automated External Defibrillator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartSine samaritan® Public Access Automated External Defibrillators and Accessories

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·MENICON SF-P RGP (MELAFOCON A) CONTACT LENS

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF RESTOR POSTERIOR CHAMBER INTRAOCULAR LENSES

Stent, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval

FDA Class 3 ·Zilver® PTX® Drug-Eluting Peripheral Stent

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·CyPass System 241-S

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Zilver Vascular Stent

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·NIDEK EC-5000 EXCIMER LASER

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·samaritan Public Access Automated External Defibrillators and Accessories

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·ZILVER VASCULAR STENT AND ZILVER VASCULAR STENT WITH RAPID EXCHANGE DELIVERY SYSTEM

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)