3,206 results · 16ms · Sources: EU EUDAMED, US FDA

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·Superion Indirect Decompression System

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·Superion™ Indirect Decompression System (IDS)

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval
FDA Class 3 ·CARDIOGENESIS TMR 2000 HOLMIUM LASER SYSTEM

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval
FDA Class 3 ·ECLIPSE TMR HOLMIUM LASER SYSTEM

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·CRCDx RAS Mutation Detection Assay Kit

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·Praxis Extended RAS Panel

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·COBAS KRAS MUTATION TEST

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·THERAPY DUAL 8 CATHETER (NON-IRRIGATED), THERAPY 8MM THERMISTOR ABLATION CATHERER (NON-IRRIGATED) SAFIRE TX CATHETER (NO

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

FDA Pre-Market Approval
FDA Class 3 ·HER2 IQFISH PHARMDX

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

FDA Pre-Market Approval
FDA Class 3 ·HER2 FISH PHARMDX KIT

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·HERCEP TEST

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

FDA Pre-Market Approval
FDA Class 3 ·DAKOCYTOMATION HER2 FISH PHARMDX KIT

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

FDA Pre-Market Approval
FDA Class 3 ·HER2 FISH PHARMADX KIT

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·DAKOCYTOMATION HERCEP TEST

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

FDA Pre-Market Approval
FDA Class 3 ·DAKOCYTOMATION HER2 FISH PHARMDX KIT

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·HERCEPTEST KIT

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·HERCEP TEST

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·HERCEPTEST

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·HERCEPTEST

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·HERCEPTEST