10,000 results · 36ms · Sources: EU EUDAMED, US FDA

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