120 results · 18ms · Sources: EU EUDAMED, US FDA

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS KRO,KR10,KBO,KB10,OF10,OB10,KN10,NB10 LENS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS KRO,KR10,KBO,KB10,OF10,OB10,KN10,NB10 LENS

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval
FDA Class 3 ·BIRMINGHAM HIP RESURFACING (BHR) SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartWare Ventricular Assist System

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·RITHRON-XR CORONARY STENT SYSTEM

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Philips HeartStart FR3 Defibrillator

Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)

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

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval
FDA Class 3 ·Trufill n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval
FDA Class 3 ·TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM

Intraocular Pressure Lowering Implant

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

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval
FDA Class 3 ·TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM

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

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval
FDA Class 3 ·TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC 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