353 results · 18ms · Sources: EU EUDAMED, US FDA

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)

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

Mr-Guided Focused Ultrasound System

FDA classification
FDA Class 3 ·Mr-Guided Focused Ultrasound System

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA classification
FDA Class 3 ·Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided