Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Therascreen EGFR, RGQ, PCR Kit

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Codman 3000 Refill Kit

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT AFP (LN 3P36)

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

FDA Pre-Market Approval

FDA Class 3 ·Oncomine Dx Target Test

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT Free PSA (LN 6C07)

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval

FDA Class 3 ·PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY (V619IMUS)

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ITREL, SYNERGY AND SYNERGY VERSITREL NEUROSTIMULATORS

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·Therakos Cellex Photopheresis System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC NEUROSTIMULATION SYSTEM (ITREL 3, RESTORE, SYNERGY, SYNERGY VERSITREL SYNERGY PLUS+, AND SYNERGY COMPACT PLUS+

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Roche cobas KRAS Mutation Test /Roche cobas DNA Sample Preparation Kit

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur and Atellica IM cPSA

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINILINK TRANSMITTER, WATERTIGHT TESTER, MINILINK KIT WITH ENLITE SERTER AND MINILINK REPLACEMENT KIT

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·Path Vysion HER-2 DNA Probe Kit

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur and Atellica IM HBc Total

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·Vysis ALK Break Apart Fish Probe Kit

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur and Atellica IM HBsAgII

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval

FDA Class 3 ·Parvovirus B19 IgM Enzyme Immunoassay

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

FDA Pre-Market Approval

FDA Class 3 ·QDOT MICRO Uni-Directional Navigation Catheter

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Cobas HBV Test