Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System, Ascenda Intrathecal Catheters

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·CyPass System, CyPass Ultra System, CyPass Micro-Stent

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Symfony Toric II OptiBlue Extended Range of Vision (ERV) IOL

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·SUTURE TRIMMER FOR THE CLOSER II 6FR. SUTURE-MEDIATED CLOSURE (SMC) SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Mara Water Vapor Ablation System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACUITY SPIRAL LEAD

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·MATRITECH NMP22 TEST KIT

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Helistat, Helitene Absorbable Collagen Hemaostatic Agents

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Collastat Absorbable Collagen Hemostatic Sponge Collastat Absorbable Collagen Hemostatic-Microfibrillar Form (INSTAT)

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONESHOT INTRODUCTION SYSTEM

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·CollaCote, CollaTape, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity XR Toric (comfilcon A)

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·TactiCath Quartz Contact Force Ablation Catheter

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·COLLASTAT INSTAT ABSORABLE COLLAGEN HOMESTATIC AGENTS

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·CollaCote/ CollaTape/ CollePlug/Absorbable Collegen Wound Dressings

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·HELISTAT HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENT

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 pharmDx