5,480 results · 22ms · Sources: EU EUDAMED, US FDA

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·ACS: CENTAUR AFP IMMUNOASSAY

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval
FDA Class 3 ·UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM, SOF-SENSORS ON PHILLIPS BASE MODELS MMT-7002, MMT-7003

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·LADAR VISION EXCIMER LASER SYSTEM

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval
FDA Class 3 ·VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·PARADIGM REAL TIME INSULIN PUMPS, PARADIGM REAL TIME REVEL INSULINPUMPS, GUARDIAN REAL TIME MONITOR.

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·ADATO SIL-OL 5000 SILICONE OIL SYRINGE

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM SEVEN SYSTEMS

Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

FDA Pre-Market Approval
FDA Class 3 ·LCS(R)TOTAL KNEE SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADVISA MRI

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·VNS THERAPY PERENNIAFLEX

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THXID BRAF KIT

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL Z9000

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER WITH UNIVERSAL TEMPERATURE MONITORING

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval
FDA Class 3 ·Activa®, Percept™ and SenSight™ Deep Brain Stimulation Therapy System

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval
FDA Class 3 ·AMS 700™ Inflatable Penile Prosthesis, AMS 700™ Inflatable Penile Prosthesis with InhibiZone™, AMS Ambicor Inflatable Pe

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MINIMED 530G SYSTEM

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Pre-Market Approval
FDA Class 3 ·Esteem