10,000 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS 700 Implanted Penile Prosthesis
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·REVO MRI
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·INTERSTIM
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·INVIVE CRT-P
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
FDA Pre-Market Approval
FDA Class 3
·INTERSTIM SYSTEM
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·PRODIGY IPG
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·Implantable System for Remodulin
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·SynchroMed® Infusion System, Ascenda® Intrathecal Catheters
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·VERIFLEX (LIBERTE) CORONARY STENT SYSTEMS
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·SELECTSECURE LEAD
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
FDA Pre-Market Approval
FDA Class 3
·INTERSTIM II 3058
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·EASYTRAK 2 LEADS
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·ACUITY STEERABLE
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ENTRUST AND VIRTUOSO ICDS
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ALTRUA 2, ESSENTIO, PROPONENT, and ACCOLADE
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, Astra S DR/SR MRI IPG. Astra XT DR/SR MRI IPG, Attesta D
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Powerheart® G5 AED
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·HV Splitter/Adaptor kit
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·TAXUS LIBERTE PACLITTAXEL-ELUTING CORONARY STENT SYSTEM