Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·iPro2 CGM System with Enlite Sensor

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·EverFlex™ Self-Expanding Peripheral Stent System, EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·Sodium Hyaluronate OphthalmicViscoelastic Devices (OVD), Healon PRO, Healon GV PRO, Healon5 PRO and Healon Duet PRO Dual

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·INNOVA Vascular Self-Expanding Stent System

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DuraSeal Exact Spinal Sealant (3mL), DuraSeal Exact Spinal Sealant (5mL)

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix Novus Lead

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate II™ Left Ventricular Assist System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval

FDA Class 3 ·PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE/VITATRON CRYSTALINE/EXCELLENCE+/EXCELLENCE PS+

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TELIGEN

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·PRODISC-C TOTAL DISC REPLACEMENT

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Restore Spinal Cord Stimulation Systems

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·GORE VIATORR TIPS Endoprosthesis

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGEVITY MRI Passive Fixation Leads, INGEVITY non-MRI Passive Fixation Leads

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Nucleus 24 Cochlear Implant System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Radiesse Injectable Implant

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMe Automated Pre-loaded Delivery System, Clareon Toric Aspheric

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CardioMEMS HF System