System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Endurant, Endurant II and Endurant 11s Stent Graft System

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·NEOMEND PROGEL PLEURAL AIR LEAK SEALANT

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·META-MV,PACING SYSTEM

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Avant, Entrant, Gallant, Neutrino NxT, Quadra Assura, Unify, Unify Assura, Unify Quadra

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·BJORK-SHILEY CARDIAC VALVE

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·GENESYS HTA SYSTEM

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

FDA Pre-Market Approval

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

Drug-Eluting Sinus Stent

FDA Pre-Market Approval

FDA Class 3 ·Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS), Propel C

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Biopr

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Obalon Balloon Kit

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Endurity MRI, Assurity MRI

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Onyx Zotarolimus-Eluting Coronary Stent System

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

FDA Pre-Market Approval

FDA Class 3 ·Guardant360® CDx

Stent Graft, Bypass, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·DETOUR System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biomedics 55 Asphere (ocufilcon D), Biomedics Torie (ocufilcon D) Soft (Hydrophilic) Contact Lenses for extended wear

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS INTUITY Elite Valve System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·JUVEDERM ULTRA XC INJECTABLE GEL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS 019B, 019C, 019E, 019F, 019J, & 019K

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·Aptima HPV 16 18/45 Genotype Assay

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Endurant, Endurant II, Endurant LLs talent Occluder