144 results · 19ms · Sources: EU EUDAMED, US FDA

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·DIASORIN ETI-MAK-2 PLUS

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·DISCRETE TECHNOLOGY(TM)OVER-THE-WIRE/RAPID EXCHANGE CORONARY STENT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Accessory Medical Adhesive, Accessory Mineral Oil, Accessory Vein Pick, Accessory Kit Lead Cap, Accessory Stylet TAPER 0

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·ADATO SIL 5000

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·CyPass Ultra System

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·Hydrus® Microstent

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·iStent inject Trabecular Micro-Bypass System

Femtosecond Laser System For Refractive Correction

FDA Pre-Market Approval
FDA Class 3 ·VisuMax Femtosecond Laser

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·iStent inject W Trabecular Micro-Bypass System

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·STAAR SURGICAL AQUAFLOW COLLAGEN GLAUCOMA DRAINAGE DEVICE

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·iStent inject® Trabecular Micro-Bypass System Model

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·iStent inject Trabecular Micro-Bypass System

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·Glaukos iStent Trabecular Micro-Bypass Stent System

Femtosecond Laser System For Refractive Correction

FDA Pre-Market Approval
FDA Class 3 ·VisuMax & VISUMAX 800

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·iStent inject® W Trabecular Micro-Bypass System

Femtosecond Laser System For Refractive Correction

FDA Pre-Market Approval
FDA Class 3 ·VisuMax Femtosecond Laser

Femtosecond Laser System For Refractive Correction

FDA Pre-Market Approval
FDA Class 3 ·VisuMax