10,000 results · 34ms · Sources: EU EUDAMED, US FDA

TIR/TIJ AND POLYROX

FDA 510(k)
FDA Class 3 ·Cardiovascular

STELA MODEL BJ44 AND BJ45 PACING LEADS

FDA 510(k)
FDA Class 3 ·Cardiovascular

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·PRODIGY IPG/LEADS WRENCH KIT/LEADS SERVICE KIT/VITATRON BRILLIANT S+/CAPSURE VDD LEADS/CONNECTOR PORT PIN-PLUG

Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation

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

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·HEALTHTRONICS OSSATRON

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·HEALTHTRONICS OSSATRON

Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation

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

Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation

FDA Pre-Market Approval
FDA Class 3 ·MicroTransponder Vivistim Paired VNS System (Vivistim System)

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·HEALTHTRONICS OSSATRON

Inhibitor, Peridural Fibrosis (Adhesion Barrier)

FDA Pre-Market Approval
FDA Class 3 ·ADCON-L ADHESION CONTROL IN A BARRIER GEL