10,000 results
·
44ms
·
Sources: EU EUDAMED, US FDA
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·OPEN PIVOT HEART VALVE
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·NIRXCELL COCR-CORONARY STENT ON RX SYSTEM
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·RADIESSE INJECTABLE IMPLANT
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·HeartMate 3 Left Ventricular Assist System
Tricuspid Valve Repair Device, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·TriClip G4 System
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·SUPARTZ FX
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·COBAS AMPLICOR HCV TEST
Stimulator, Hypoglossal Nerve, Implanted, Apnea
FDA Pre-Market Approval
FDA Class 3
·Inspire II Upper Airway Stimulator
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella 2.5, Impella CP and CP with SmartAssist
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·DEPUY CERMAX CERAMIC TOTAL HIP SYSTEM
Automated Insulin Dosing Device System, Single Hormonal Control
FDA Pre-Market Approval
FDA Class 3
·MiniMed 670G System, MiniMed 770G System
Analyzer, Medical Image
FDA Pre-Market Approval
FDA Class 2
·IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·PROVISC Ophthalmic Viscosurgical Device (latex-ftee packaging configuration)
Device, Thermal Ablation, Endometrial
FDA Pre-Market Approval
FDA Class 3
·Genesys Hta 115V Control Unit, Genesys Hta 115V Control Unit (Demo), Genesys Hta 115V Control Unit (Refurb), Genesys Hta
System, Laser, Transmyocardial Revascularization
FDA Pre-Market Approval
FDA Class 3
·PEARL 8.0 HANDPIECE FOR TRANSMYOCARDIAL REVASCULARIZATION (TMR) WITH THE CARDIOGENESIS HOLMIUM: YAG LASER SYSTEM
Stent, Iliac
FDA Pre-Market Approval
FDA Class 3
·EPIC VASCULAR SELF-EXPANDING STENT SYSTEM
Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·ReActiv8 Implantable Neurostimulation System
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·iSert Preloaded System
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·MANTA Vascular Closure Device, 14F, MANTA Vascular Closure Device, 18F, MANTA 8F Depth Locator, MANTA 14F Depth Locator
Valve, Pulmonary
FDA Pre-Market Approval
FDA Class 3
·The Pulmonx Zephyr Endobronchial Valve System (EBV)