318 results · 28ms · Sources: EU EUDAMED, US FDA

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·ENLITE SENSOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·IS-1 CONNECTOR PORT PIN PLUG KIT/SPRINT/QUATTRO/SUBCUTANEOUS LEAD/SUB-Q TUNNELING TOOL/TRANSVENE CS/SVC/DF1/RV/SUBQ/SVC

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·Axonics Sacral Neuromodulation System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SYNCHROMED2 PUMP FEED-THROUGHS & CATHETER ACCESSORIES

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·Axonics Sacral Neuromodulation System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 530G System

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Guardian Connect System

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·iPro2 CGM System with Enlite Sensor

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 670G System

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Paradigm Real-Time Revel System

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 670G System

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·DUETT SEALING DEVICE

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·Orsiro Mission Sirolimus Eluting Coronary Stent System

Implant, Auditory Brainstem

FDA Pre-Market Approval
FDA Class 3 ·Nucleus ABI541 Auditory Brainstem Implant

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·DROMOS DR/SR RATE ADAPTIVE PACING SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·Nucleus 24 Cochlear Implant System

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval
FDA Class 3 ·Nucleus Hybrid L24 Implant System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·EluNIR Ridaforolimus Eluting Coronary Stent System