3,927 results · 27ms · Sources: EU EUDAMED, US FDA

Telescope, Implantable, Miniature

FDA Pre-Market Approval
FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE (IMT)

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WAVELIGHT ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WAVELIGHT ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER

Drug-Eluting Sinus Stent

FDA Pre-Market Approval
FDA Class 3 ·PROPEL CONTOUR SINUS IMPLANT

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·Raindrop Near Vision Inlay

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval
FDA Class 3 ·HYPERION LTK SYSTEM

Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents

FDA Pre-Market Approval
FDA Class 3 ·Et Control

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·Flow Re-Direction Endoluminal Device (FRED®) System

Telescope, Implantable, Miniature

FDA Pre-Market Approval
FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval
FDA Class 3 ·WALLSTENT™ Endoprosthesis

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS; THEON PERICARDIAL AORTIC BIOPROSTHESIS WITH THERMALFIX TI

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS INTUITY Elite Valve System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·Promus PREMIER/ Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Edwards SAPIEN 3™ Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra™ Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra™

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS(R) BIOPROSTHESIS, MODELS 2625 AND 6625