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

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas® EGFR Mutation Test, v2.0

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas® BRAF V600 Mutation Test

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test, v2.0

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas® KRAS Mutation Test

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ENVISTA HYDROPHOBIC ACRYLIC INTRAOCULAR LENS (IOL)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·enVista Hydrophobic Acrylic Intraocular Lens (IOL)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·E P TECH CARDIAC ABLATION SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·CHILLI COOLED ABLATION CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·CHILLI AND CHILLI RPM COOLED ABLATION SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·EPT-1000 XP CARDIAC ABLATION SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·EPT-1000 XP CARDIAC ABLATION SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·E P TECH EPT-1000 CARDIAC ABLATION SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·EPT 1000TC AND EPT 1000XP CARDIAC ABLATION SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·EPT 1000TC AND EPT 1000XP CARDIAC ABLATION SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·EPT-1000 TC CARDIAC ABLATION SYSTEM WITH TEMPERATURE CONTROL

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·EPT-1000 CARDIAC ABLATION SYSTEM

Telescope, Implantable, Miniature

FDA Pre-Market Approval
FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE (IMT)

Telescope, Implantable, Miniature

FDA Pre-Market Approval
FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE (IMT)

Telescope, Implantable, Miniature

FDA Pre-Market Approval
FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE (IMT)