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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·#2 BI-DIRETIONAL TORQUE WRENCH

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER (EPTC) EXT CBL, SAFIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, EXT CBL, S

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT (ABI)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM (ABI)

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

Somatic Gene Mutation Detection System

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

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim Therapy System (Bowel)

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Restore, Itrel, and Synergy Spinal Cord Stimulation System and Pisces, Specify and Vectris Spinal Cord Stimulation Leads

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Master Restore, Itrel and Synergy Spinal Cord Stimulation Systems, Intellis Implantable Neurostimulation System and Pisc

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim Therapy System (Urinary)

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

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

Acute Coronary Syndrome Event Detector

FDA Pre-Market Approval
FDA Class 3 ·AngelMed Guardian System

Acute Coronary Syndrome Event Detector

FDA Pre-Market Approval
FDA Class 3 ·AngelMed Guardian System

Acute Coronary Syndrome Event Detector

FDA Pre-Market Approval
FDA Class 3 ·Guardian System

Acute Coronary Syndrome Event Detector

FDA Pre-Market Approval
FDA Class 3 ·AngelMed Guardian System

Acute Coronary Syndrome Event Detector

FDA Pre-Market Approval
FDA Class 3 ·AngelMed Guardian® System

Acute Coronary Syndrome Event Detector

FDA Pre-Market Approval
FDA Class 3 ·Guardian System

Acute Coronary Syndrome Event Detector

FDA Pre-Market Approval
FDA Class 3 ·AngelMed Guardian System

Acute Coronary Syndrome Event Detector

FDA Pre-Market Approval
FDA Class 3 ·Guardian® System

Acute Coronary Syndrome Event Detector

FDA Pre-Market Approval
FDA Class 3 ·Guardian System