Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

FDA Pre-Market Approval

FDA Class 3 ·AvertD and AvertD Buccal Sample Collection Kit

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT.

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Y ADAPTOR/EXTENDER KIT, SPRINT QUATTRO LEAD

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 8516 PERCUTANEOUS INTRASPINAL CATHETER KIT

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

FDA Pre-Market Approval

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

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·HV splitter/adaptor kit; Sprint Quattro Lead

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

FDA Pre-Market Approval

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

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·HV Splitter/Adaptor Kit, Sprint Quattro Lead.

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Y Adaptor/Extender Kit, Sprint Quattro Lead

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT

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

FDA Pre-Market Approval

FDA Class 3 ·PATH VYSION HER-2 DNA PROBE KIT

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·QUANTITOPE 125I AFP KIT AND CONTROL SERUM

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC HALL/EASY-FIT PROSTHETIC HEART VALVE

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·Vysis ALK Break Apart Fish Probe Kit

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·Therakos Uvar XTS Photopheresis System Procedural Kit.

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·HV Splitter/Adaptor kit, Sprint Quattro Lead

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 ·HBSAG REAGENT PACK/CALIBRATOR & CONFIRMATORY KIT

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·QUANTITOPE 125I AFP KIT AND CONTROL SERUM