10,000 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·BLAZER II AND BLAZER II XP CARDIAC ABLATION CATHETERS
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·DEMA FAMILIES/C & T SERIES DEVICES
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ABBOTT ARCHITECT FREE PSA
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·DISCOVERY/ MERIDIAN
Stent, Urethral, Prostatic, Semi-Permanent
FDA Pre-Market Approval
FDA Class 3
·THE SPANNER TEMPORARY PROSTATIC STENT
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·BD PREPSTAIN SYSTEM
System, Laser, Photodynamic Therapy
FDA Pre-Market Approval
FDA Class 3
·BLU-U
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·TALENT THORACIC STENT GRAFT SYSTEM
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·VERIFLEX OTW BARE-METAL CORONARY STENT SYSTEM
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·CLARION CII BIONIC EAR SYSTEM HIFOCUS ELECTRODE
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS TOTAL KNEE SYSTEM
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·LATITUDE PATIENT MANAGEMENT SYSTEM SOFTWARE
Fluid, Intraocular
FDA Pre-Market Approval
FDA Class 3
·PERFLURON
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·MICRO-DRIVER OVER-THE-WIRE CORONARY STENT SYSTEM AND MICRO-DRIVER MX2 CORONARY STENT SYSTEM
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
FDA Pre-Market Approval
FDA Class 3
·INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·VASCULAR SOLUTIONS DUETT SEALING DEVICE
Transcatheter Septal Occluder
FDA Pre-Market Approval
FDA Class 3
·GORE HELEX SEPTAL OCCLUDER
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·POSTERIOR CHAMBER MONOFOCAL
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·BIOFINITY XR