Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·BIOMERIEUX THXID BRAF ASSAY KIT

System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·ColoSense

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·Paradigm Spine Coflex Interlaminar Stabilization Device

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THXID-BRAF KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THXID BRAF KIT

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·VIDAS TOTAL PSA

System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·ColoSense

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LASERVISION/VISX EXCIMER LASER FOR PRK AND PTK (MOBILEXCIMER)

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·coflex® Interlaminar Technology

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THxID-BRAF assay kit

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·VIDAS TOTAL PSA (TPSA)

System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·ColoSense®

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THxID-BRAF kit

System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·ColoSense

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LASERVISION/VISX EXCIMER LASER MODEL C

Mitral Valve Repair Devices

FDA classification

FDA Class 3 ·Mitral Valve Repair Devices

Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

FDA classification

FDA Class 3 ·Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

Immunohistochemistry Antibody Assay, C-Kit

FDA classification

FDA Class 3 ·Immunohistochemistry Antibody Assay, C-Kit

Intraocular Pressure Lowering Implant

FDA classification

FDA Class 3 ·Intraocular Pressure Lowering Implant

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA classification

FDA Class 3 ·Aortic Valve, Prosthesis, Percutaneously Delivered