Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FluoroPerm 92, FluoroPerm 60, FluoroPerm 30, FluoroPerm 151, HDS and HDS 100

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·CDS II (SODIUM CHONDROITIN SULFATE)

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISIONS MADE WITH PARAGON HDS (PAFLUFOCON B)

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·CERVISTA HPV HR AND DNA EXTENSION KIT

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Paragon HDS® (paflufocon B), FluoroPerm® 151 (paflufocon D), Paragon HDS® 100 (paflufocon D) Rigid Gas Permeable Contac

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MITRACLIP NT CLIP DELIVERY SYSTEM

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip G4 System

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip G4 Clip Delivery System; MitraClip G5 Delivery System

Tricuspid Valve Repair Device, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·TriClip G4 Delivery System;TriClip G5 Delivery System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD 2, CONTAK RENEWAL 3 DS, CONTAK RENEWAL 3 HE

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FluoroPerm30 (paflufocon C), FluoroPerm60 (paflufocon B), FluoroPerm92 (paflufocon A), Paragon HDS (paflufocon B) Rigid

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·ASPIRE Cristalle Breast Tomosynthesis System

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·CERVISTA

Tricuspid Valve Repair Device, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·TriClip™ G4 Clip Delivery System

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Paragon HDS 100 and Fluoroperm 151 (paflufocon D) Rigid Gas Permeable Contact Lens in Clear and Tints

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC DBS THERAPY FOR PARKINSON'S DISEASE

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MITRACLIP DELIVERY SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME REVEL SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM SEVEN AND SEVEN PLUS