Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·SPOT-LIGHT HER2 CISH KIT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Lead Repair Kit Model 6946

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SIDE CATHETER ACCESS PORT KITS

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA Pre-Market Approval

FDA Class 3 ·Vysis CLL FISH Probe Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·therascreen PIK3CA RGQ PCR Kit

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA Pre-Market Approval

FDA Class 3 ·Vysis CLL FISH Probe Kit

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·FLEXTIP PLUS INTRASPINAL CATHETER KIT

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Anchoring Sleeve Kit, SelectSecure Lead

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE/CAPSURE MODEL/SERVICE KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THERASCREEN EGFR RGQ PCR KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·therascreen EGFR RGQ PCR Kit

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·AFP/OB(TM) RIA KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·therascreen KRAS RGQ PCR Kit

Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

FDA Pre-Market Approval

FDA Class 3 ·URO VYSION BLADDER CANCER KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·therascreen KRAS RGQ PCR Kit

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·HV splitter/adaptor kit 5019

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-AB-COREK PLUS KIT

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·SPOT-LIGHT HER2 CISH KIT

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-AB-EBK PLUS KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THERASCREEN EGFR RGQ PCR KIT