550 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Agent, Bulking, Injectable For Gastro-Urology Use
FDA Pre-Market Approval
FDA Class 3
·SOLESTA
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·NATRELLE SILICONE-FILLED BREAST IMPLANTS.
System, Appendage Closure, Left Atrial
FDA Pre-Market Approval
FDA Class 3
·WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) DEVICE
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·CRYOCOR CRYOABLATION SYSTEM
Implant, Anti-Gastroesophageal Reflux
FDA Pre-Market Approval
FDA Class 3
·Linx Reflux Management System
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLQTINUM CHROMIUM STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·STAT S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM
Stimulator, Hypoglossal Nerve, Implanted, Apnea
FDA Pre-Market Approval
FDA Class 3
·INSPIRE II UPPER AIRWAY STIMULATOR
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·ION (TAXUS ELEMENT) PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL) & OTW
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·HIGH CYLINDER POWER ACRYSOF IQ TORIC IOLS
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·CERAMAX (R) CERAMIC TOTAL HIP SYSTEM
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL DEFLECTABLE DIAGNOSTIC / ABLATION CATHETERS
Lens, Intraocular, Phakic
FDA Pre-Market Approval
FDA Class 3
·IMPLANTABLE COLLAMER LENS (VISIAN ICL)
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·MEMORYGEL BREAST IMPLANT
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·TALENT CONVERTER STENT GRAFT SYSTEM AND TALENT OCCLUDER SYSTEM
Transcervical Contraceptive Tubal Occlusion Device
FDA Pre-Market Approval
FDA Class 3
·ESSURE SYSTEM
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ACUITY SPIRAL LEAD
Stent, Superficial Femoral Artery
FDA Pre-Market Approval
FDA Class 3
·BARD LIFESTENT VASCULAR STENT SYSTEM