Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·Hydrus® Microstent

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK 8 AND MULTI-LINK 8 LL CORONARY STENT SYSTEM

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INTERPORE PRO OSTEAN(R)IMPLANT 500 COR. HYDROX

Electrosurgical, Radio Frequency, Refractive Correction

FDA Pre-Market Approval

FDA Class 3 ·VIEWPOINT CK SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·MINILINK(MODELS MMT-7703 TRANSMITTER, MMT-7705 CHARGER, MMT-7706 TEST PLUG)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·META DDDR PACING SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·JUVEDERM VOLUMA XC

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS AMPLIPREP/COBAS TAQMAN HBV V2.0 TEST FOR USE WITH THE HIGH PURE SYSTEM

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Intuity Elite Valve System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·iPro2 CGM System with Enlite Glucose Sensor

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·Rapid fFN for the TLiIQ System

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Allure RF, Allure Quadra RF, Allure Quadra, Allure, Quadra Allure MP,Quadra Allure MP RF

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvederm Ultra, Ultra XC, Ultra Plus, and Juvederm Ultra Plus XC

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Tecnis 3-Piece Multifocal IOL

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY ABLATION CATHETER INCLUDING BI-DIRECTIONAL CATHETER AND THERAPY 4MM THERNISTOR ABLATION CATHETER

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards INSPIRIS RESILIA Aortic Valve and Edwards Pericardial Aortic Bioprosthesis

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards Intuity Elite Valve System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Tetrafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·Medtronic MiniMed 670G System