315 results · 20ms · Sources: EU EUDAMED, US FDA

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·COFLEX® INTERLAMINAR TECHNOLOGY

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·COFLEX® INTERLAMINAR TECHNOLOGY

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·coflex® Interlaminar Technology

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

FDA Pre-Market Approval
FDA Class 3 ·VIDAS FREE PSA (FPSA) ASSAY

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·HELIOS II ABLATION CATHETER

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®

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

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THXID BRAF KIT

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

FDA Pre-Market Approval
FDA Class 3 ·VIDAS FREE PSA RT

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

FDA Pre-Market Approval
FDA Class 3 ·VIDAS TOTAL PSA

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·coflex Interlaminar Stabilization Device

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

FDA Pre-Market Approval
FDA Class 3 ·VIDAS TOTAL PSA (TPSA) ASSAY

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 ·coflex Interlaminar Technology

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THXID-BRAF KIT

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·MOBILEXCIMER FOR PTK AND PRK

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

FDA Pre-Market Approval
FDA Class 3 ·VIDAS TOTAL PSA (TPSA) ASSAY

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

FDA Pre-Market Approval
FDA Class 3 ·VIDAS TOTAL PSA (TPSA) ASSAY