10,000 results · 30ms · Sources: EU EUDAMED, US FDA

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·FLEX34 Active Electrode, Insertion Electrode (IE) FLEX34, Insertion Probe, Insertion Probe L and Auditory Nerve Test Sys

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·COMBI 40+ COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·COMBI 40+ COCLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·COMBI 40+ COCHLEAR IMPLANT SYSTEM (MAESTRO COCHLEAR IMPLANT SYSTEM)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·Combi 40+ Cochlear Implant System

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MAESTRO System Software 9.0

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·TECHNOLAS 217Z ZYOPTIX SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Bellafill Dermal Filler

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval
FDA Class 3 ·CILCO ND:YAG LASER

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval
FDA Class 3 ·CILCO ND:YAG LASER

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·MODEL 2901 PROGRAMMERR SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·VOLTA(1CR/2CR/CT/2CT) ICD LEAD, PROTEGO (S/SD/T/TD) ICD LEAD,KAINOX VCS 60 ICD LEADLINOX SMART (S/SD/T/TD/S DX) ICD LEAD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·DEXTRUS, SELOX ST/JT, SETROX S, AND TILDA T/JT/R STEROID-ELUTING PACING LEADS; SOLOX SLX -BP PACING LEAD

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SURESTREAM INTRASPINAL CATHETER KIT (60-2918) & SURESTREAM REPLACEMENT CONNECTOR AND STRAIN RELIEF SLEEVE (60-2950)

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·CELERITY 2D/3D/PILOT STEROID-ELUTING LV LEAD, COROX (-S/-L) BP STEROID-ELUTING LV LEAD

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·ATTAIN STARFIX LEAD