2,328 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·ALTO SHOCK 4 MODULES
Enzyme Immunoassay, Fetal Fibronectin
FDA Pre-Market Approval
FDA Class 3
·RAPID FFN CONTROL KIT
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·DURASOFT 3 (PHEMFILCON A) UV OPTIFIT TORIC AND SPHERICAL CONTACT LENSES
Stent, Superficial Femoral Artery
FDA Pre-Market Approval
FDA Class 3
·EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·CHILLI COOLED ABLATION SYSTEM FOR THE CIRCUCOOL PUMP
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL PUMP, PARADIGM REAL-TIME PUMP, AND GUARDIAN REAL-TIME MONITOR
Automated Insulin Dosing Device System, Single Hormonal Control
FDA Pre-Market Approval
FDA Class 3
·MiniMed 670G System
Ventilator, High Frequency
FDA Pre-Market Approval
FDA Class 3
·LifePulse High Frequency Ventilator
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·THIN PREP PROCESSORS
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·VARIOUS MODELS ICD'S TMS 1000 PLUS
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·Guardian Connect system
Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·MiniMed 530G System
Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·MiniMed 630G System
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·MiniMed iPro2 CGM System with Enlite Sensor
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·FEMORAL INTRODUCER SHEATH & HEMOSTASIS (FISH) DEVICE
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·MiniMed Paradigm Real-Time Revel System
Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
FDA Pre-Market Approval
FDA Class 3
·LCS UNI KNEE SYSTEM
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·FREESTYLE NAVIGATOR
Digital Breast Tomosynthesis
FDA Pre-Market Approval
FDA Class 3
·Senographe Pristina 3D
Stimulator, Autonomic Nerve, Implanted For Epilepsy
FDA Pre-Market Approval
FDA Class 3
·VNS Therapy System