Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DURASEAL (R) EXACT SPINE SEALANT SYSTEM

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Smartablate System Interface Cable

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator

Valve, Pulmonary

FDA Pre-Market Approval

FDA Class 3 ·Spiration® Valve System (SVS)

Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

FDA Pre-Market Approval

FDA Class 3 ·Cartiva Synthetic Cartilage Implant

Microspheres Radionuclide

FDA Pre-Market Approval

FDA Class 3 ·TheraSphere

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TRANSVENE,SQ,SPRINT AND SPRINT FIDELIS LEAD MODELS AND ACCESSORIES

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·ProCol Vascular Bioprosthesis

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Lap-Band Adjustable Gastric Banding System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·TENDRIL FAMILY F LOW VOLTAGE LEADS

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·Tridyne Vascular Sealant

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

FDA Pre-Market Approval

FDA Class 3 ·Corox OTW BP

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Blazer II Cardiac Ablation Catheter and Cable

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 PharmDx

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·GORE® CARDIOFORM ASD Occluder

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PERCLOSE PROGLIDE SUTURE-MEDIATED CLOSURE DEVICE

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNXGRIP VASCULAR CLOSURE DEVICE (5F, 6F/7F)

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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBc IgM, PreciControl Anti-HBc IgM