2,142 results · 19ms · Sources: EU EUDAMED, US FDA

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 630G System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 530G Insulin Pump

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 670G System

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Paradigm real time Insulin Pump / Paradigm Real time revel Insulin Pump

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Paradigm Real Time Revel Insulin Pump

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS Family of 1-piece IOLs packaged in the Daisy Wheel Configuration

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·METHAFILCON A AND METHAFILCON B SOFT HYDROPHILIC WEAR CONTACT LENSES INSTALLATION AND VALIDATION OF A NEW 3M ATTEST 290

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

Imager, Breast, Electrical Impedance

FDA Pre-Market Approval
FDA Class 3 ·T-SCAN 2000

Imager, Breast, Electrical Impedance

FDA Pre-Market Approval
FDA Class 3 ·TS2000

Imager, Breast, Electrical Impedance

FDA Pre-Market Approval
FDA Class 3 ·TRANSCAN T-SCAN 2000

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

Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation

FDA Pre-Market Approval
FDA Class 3 ·PINNACLE COMPLETE ACETABULAR HIP 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

Drug-Eluting Sinus Stent

FDA Pre-Market Approval
FDA Class 3 ·PROPEL MINI SINUS IMPLANT

Drug-Eluting Sinus Stent

FDA Pre-Market Approval
FDA Class 3 ·Propel® Contour Sinus Implant

Drug-Eluting Sinus Stent

FDA Pre-Market Approval
FDA Class 3 ·Propel and Propel Mini Sinus Implants