Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·Gelsyn-3

Valve, Pulmonary

FDA Pre-Market Approval

FDA Class 3 ·Zephyr Endobronchial Valve System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Revanesse Versa, Revanesse Versa+ and Revanesse Lips+

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Guardant360 CDx

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·APLIGRAF (GRAFTSKIN)

System, Laser, Fiber Optic, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·OPTIGUIDE (TM) CYLINDRICAL FIBER OPTIC

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·SPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED II PUMP MODEL 8637

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·EON TM, EONC TM, PROTEGE, PROTEGE MRI AND BRIO IMPLANTABLE PULSE GENERATOR

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS Therapy® SenTiva® Model 1000 Generator, VNS Therapy® AspireSR Model 106 Generator, VNS Therapy® Demipulse Model 103

Agent, Injectable, Embolic

FDA Pre-Market Approval

FDA Class 3 ·ONYX LIQUID EMBOLIC SYSTEM

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS Total Knee System

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·PRECICONTROL HBSAG

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·PRECICONTROL ANTI-HBC IGM (COBAS E 601)

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·PRECICONTROL ANTI-HBC (MODULAR ANALYTICS E170)

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Pipeline™ Flex Embolization Device and Pipeline™ Flex Embolization Device with Shield Technology™

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·PRECICONTROL ANTI-HBC IGM (MODULAR ANALYTICS E170)

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL COCHLEAR IMPLANT SYSTEMS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·PRECICONTROL ANTI-HBC IGM (COBAS E 411)