322 results · 17ms · Sources: EU EUDAMED, US FDA

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·Protégé RX Carotid Stent System; Protégé GPS Self-expanding Peripheral Stent System

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·Protégé™ RX Carotid Stent System, Protégé™ GPS™ Self-Expanding Peripheral Stent System

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·Protégé™ RX Carotid Stent System, tégé™ GPS™ Self-Expanding Peripheral Stent System

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·Protégé GPS Self-Expanding Peripheral Stent System, Protégé RX Carotid Stent System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Saluda Medical Evoke SCS System

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval
FDA Class 3 ·Paragon Z CRT (tisilfocon A) Rigid Gas Permeable Contact Lenses in Blue Tint

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·Protégé RX Self-expanding Stent System, Protégé GPS Self-Expanding Peripheral Stent System

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·Protégé™ GPS™ Self-Expanding Peripheral Stent System, and Protégé™ RX Carotid Stent System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·(MBX, MHY, NHL, PJS) -Master Percept and Activa Deep Brain Stimulation Therapy Systems

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·MODEL 3100A HIGH FREQUENCY OSCILLATORY VENTILATOR

Drug-Eluting Sinus Stent

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

Gastric Emptying Breath Test

FDA Pre-Market Approval
FDA Class 3 ·13C-Spirulina Gastric Emptying Breath Test (GEBT)

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Prospera SCS System, Resilience Surgical Lead

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·PROMUS Everolimus-Eluting Coronary Stent System

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Ranger Paclitaxel-Coated PTA Balloon Catheter

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·NexGen® LPS-Flex / LPS-Mobile Bearing Knee

Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents

FDA Pre-Market Approval
FDA Class 3 ·Et Control

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval
FDA Class 3 ·PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM