1,127 results · 20ms · Sources: EU EUDAMED, US FDA

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·EluNIR™ Ridaforolimus Eluting Coronary Stent System

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·NIRFLEX PREMOUNTED CORONARY STENT SYSTEM

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Abbott Real Time HBV Amplification Reagent Kit / HBV Control Kit / HBV Calibrator Kit

Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

FDA Pre-Market Approval
FDA Class 3 ·URO VYSION BLADDER CANCER KIT

Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

FDA Pre-Market Approval
FDA Class 3 ·UROVYSION BLADDER CANCER KIT

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval
FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·NIRXCELL COCR CORONARY STENT ON RX SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·EluNIR™ Ridaforolimus Eluting Coronary Stent System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·EluNIR™ Ridaforolimus Eluting Coronary Stent System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·EluNIR-PERL™ Ridaforolimus Eluting Coronary Stent System

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval
FDA Class 3 ·UroVysion Bladder Cancer Kit

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Alinity m HBV

Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

FDA Pre-Market Approval
FDA Class 3 ·UroVysion Bladder Cancer Kit

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·NIRxcell CoCr Coronary Stent on RX System

Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

FDA Pre-Market Approval
FDA Class 3 ·Urovysion Bladder Cancer Kit

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

FDA Pre-Market Approval
FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·NIRFLEX PREMOUNTED CORONARY STENT SYSTEM

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT REALTIME HBV

Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

FDA Pre-Market Approval
FDA Class 3 ·UROVYSION BLADDER CANCER KIT

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

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