10,000 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Automated Insulin Dosing Device System, Single Hormonal Control
FDA Pre-Market Approval
FDA Class 3
·MiniMed 670G System
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·COBAS TaqMan HBV Test, High Pure System Viral Nucleic Acid Kit
Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·MiniMed 630G System with SmartGuard
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·ANEURX AAADVANTAGE STENT GRAFT WITH THE XCELERANT DELIVERY SYSTEM
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·CELSIUS RMT CATHETER
Device. Laser Peripheral Angioplasty
FDA Pre-Market Approval
FDA Class 3
·TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE
Drug-Eluting Peripheral Transluminal Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·enVista Hydrophobic Acrylic Intraocular Lens (IOL)
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·XIENCE V and XIENCE Nano EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
Intracranial Aneurysm Flow Diverter
FDA Pre-Market Approval
FDA Class 3
·Surpass Evolve Flow Diverter System
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·QDOT Micro Navigation Catheter
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS), CEEON MODELS 911A & 913A, TECNIS Z9000
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·ZYDERM COLLAGEN IMPLANT (ZYDERM CI)
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·ENLITE SENSOR
System, Laser, Transmyocardial Revascularization
FDA Pre-Market Approval
FDA Class 3
·CARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODELS 019B, 019C, 019E, 019F, 019J, & 019K
Stent, Iliac
FDA Pre-Market Approval
FDA Class 3
·ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·TECNIS CL FOLDABLE SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL Z9002)
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Leadless Pacemaker
FDA Pre-Market Approval
FDA Class 3
·Aveir Leadless System