Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SERVICE KIT-PACEMAKER REPAIR KIT,VITATRON BRILLIANT S+ VDD LEAD

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE Reagent Kit, Alinity i Anti-HBc Reagent Kit

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

FDA Pre-Market Approval

FDA Class 3 ·EVIA HF,EVIA HF-T, ENTOVIS HF,ENTOVIS HF-T

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

FDA Pre-Market Approval

FDA Class 3 ·EVIA HF,EVIA HF-T, ENTOVIS HF, ENTOVIS HF-T

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·IIivia, 7 HF-T,QP; Intica 7,5 HF-T,QP

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

FDA Pre-Market Approval

FDA Class 3 ·EVIA HF, EVIA HF-T, ENTOVIS HF, ENTOVIS HF-T

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·DRG Lead Extension Kit, SlimTip DRG Trial/Implant Lead Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THXID BRAF KIT

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·AFP RIA KIT

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·ENTERYX PROCEDURE KIT

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

FDA Pre-Market Approval

FDA Class 3 ·Manual Retraction Kit

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·AUTODELFIA HAFP KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THxID-BRAF kit

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Obalon Balloon Kit

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·INFUSAID REFILL KIT

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·C-KIT PHARMDX

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ANCHORING SLEEVE KIT

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·ENTERYX PROCEDURE KIT

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·C-Kit pharmDx

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THXID BRAF KIT