Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

Immunohistochemistry Assay, Antibody, Ki-67

FDA Pre-Market Approval

FDA Class 3 ·Ki-67 IHC pharmDx

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY COOL PATH DUO CATHETER(12 HOLE IRRIGATED),SAFIRE BLU DUO CATHETER(12 HOLE IRRIGATED),COOL PATH DUO ABLATION

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY COOL PATH DUO CATHETER (12 HOLE IRRIGATED), SAFIRE BLU DUO CATHETER(12 HOLE IRRIGATED), COOL PATH DUO ABLATION C

Stimulator, Autonomic Nerve, Implanted (Depression)

FDA Pre-Market Approval

FDA Class 3 ·PULSE/PULSE DUO GENERATOR; DEMIPULSE/DEMIPULSE DUO GENERATOR; ASPIREHC GENERATOR; ASPIRESR GENERATOR

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·DAKO C-KIT PHARMDX

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

FDA Pre-Market Approval

FDA Class 3 ·DAKO EGFR PHARMDX KIT

Stent, Iliac Vein

FDA Pre-Market Approval

FDA Class 3 ·Duo Venous Stent System

Stent, Iliac Vein

FDA Pre-Market Approval

FDA Class 3 ·Duo Venous Stent System

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·Demipulse™ Generator; Demipulse Duo™ Generator, AspireSR™ Generator, SenTiva™ Generator; SenTiva Duo™ Generator, Symmetr

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

FDA Pre-Market Approval

FDA Class 3 ·Therapy Cool Flex, Path Duo, Safire Duo, MediGuide Enabled Ablation Catheter; Mediguide Enabled

Stimulator, Autonomic Nerve, Implanted (Depression)

FDA Pre-Market Approval

FDA Class 3 ·PULSE AND PULSE DUO GENERATORS, DEMIPULSE AND DEMIPULSE DUO GENERATORS, ASPIREHC MODEL 105 GENERATOR

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY COOL PATH DUO CATHETER

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·SenTiva™ Generator, SenTiva Duo™ Generator

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

FDA Pre-Market Approval

FDA Class 3 ·SAFIRE BLU DUO ABLATION CATHETERS

Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

FDA Pre-Market Approval

FDA Class 3 ·DAKO TOP2A FISH PHARMDX KIT

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·INTEGRITY AFX DR MODEL 5346

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PROFILE MD (MODELS V-186F AND V-186HV3), PHOTON DR (MODEL V-230HV) AND PHOTON U VR/DR IMPLANTABLE CARDIOVERTER

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·INTEGRITY AFX DR MODEL 5346

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·SPINALOGIC 1000 BONE GROWTH STIMULATOR