207 results · 20ms · Sources: EU EUDAMED, US FDA

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NEUROPACE RNS SYSTEM

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NEUROPACE RNS SYSTEM

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NeuroPace Remote Monitor

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NeuroPace® RNS® System

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NEUROPACE RNS SYSTEM

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NEUROPACE RNS SYSTEM

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NEUROPACE RNS SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL COCHLEAR IMPLANT SYSTEMS (COMBI40+, PULSARCI100, SONATATI100, MED-EL CONCERT, & MED-EL CONCERT PIN)

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·HV Splitter/Adaptor kit, IS-1 Connector Port Pin Plug Kit, Sprint Quattro Lead, Subcutaneous Lead

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·IS-1 CONNECTOR PORT PIN PLUG KIT, SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/ACCESSORY (UPSIZING SLEEVE)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ACCESSORY (UPSIZING SLEEVE)/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/ GEM/PCD TACHY CONTROL SYSTEM/JEWEL/LEAD END PIN

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ACCESSORY (UPSIZING SLEEVE)/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/ GEM/PCD TACHY CONTROL SYSTEM/JEWEL/LEAD END PIN

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·LEAD ADAPTOR, IS-1 PORT PIN PLUG, SPRINT, SPRINT FIDELIS, QUATTRO, QUATTRO SECURE & SUBCUTANEOUS DEFIBRILLATION LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ACCESSORY (UPSIZING SLEEVE)/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/GEM/PCD TACHY CONTROL SYSTEM/JEWEL/LEAD END PIN CAP

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EPICARDIAL TRANSVENE/CABLE/ACE HEADER/UPSIZING SLEEVE FOR HV LEAD DF-1/UPSIZING SLEEVE/LEAD END PIN CAP

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·IS-1 PORT PIN PLUG/Y ADAPTOR KIT/LEAD ADAPTOR/SPRINT LEAD/QUATTRO/QUATTRO SECURE/SUBCUTANEOUS DEFIBRILLATION/TRANSVENE