39 results · 22ms · Sources: EU EUDAMED, US FDA

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

FDA Pre-Market Approval
FDA Class 3 ·GENESEARCH BREAST LYMPH NODE (BLN) ASSAY

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

FDA Pre-Market Approval
FDA Class 3 ·GENESEARCH BREAST LYMPH NODE(BLN) ASSAY

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Azure S DR/SR MRI IPG and Azure XT DR/SR MRI IPG

Leadless Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·Micra AV TPS, Micra TPS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Master Restore, Itrel®, Synergy® and Intellis Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® Spinal

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SynchroMed® Infusion System, Ascenda® Intrathecal Catheters

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

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

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·GEMNOS(TM) 04 CARDIAC PACEMAKER & SWN 600/C00U02

Stent Graft, Infrapopliteal, Venous Arterialization

FDA Pre-Market Approval
FDA Class 3 ·LimFlow System

Stent Graft, Infrapopliteal, Venous Arterialization

FDA Pre-Market Approval
FDA Class 3 ·LimFlow System

Stent Graft, Infrapopliteal, Venous Arterialization

FDA Pre-Market Approval
FDA Class 3 ·LimFlow System

Stent Graft, Infrapopliteal, Venous Arterialization

FDA Pre-Market Approval
FDA Class 3 ·LimFlow System, LimFlow Crossing Stent Graft and LimFLow Extension Stent Graft

Stent Graft, Infrapopliteal, Venous Arterialization

FDA Pre-Market Approval
FDA Class 3 ·LimFlow System, LimFlow Crossing Stent Graft, LimFlow Extension Stent Graft

Stent Graft, Infrapopliteal, Venous Arterialization

FDA Pre-Market Approval
FDA Class 3 ·LimFlow System

Stent Graft, Infrapopliteal, Venous Arterialization

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

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·Hydrus Microstent