10,000 results · 25ms · Sources: EU EUDAMED, US FDA

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·EPIC/EPIC+/ATLAS/ATLAS+/CONVERT/CONVERT+ ICDS

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval
FDA Class 3 ·MCGHAN MEDICAL SALINE-FILLED BREAST IMPLANTS

Lens, Intraocular, Phakic

FDA Pre-Market Approval
FDA Class 3 ·Visian Implantable Collamer Lens for Myopia

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TIER B MODEL SBUV20-23DO IOL

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Carpentier-Edwards® PERIMOUNT ®Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT Theon® Pericardial Aortic

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

FDA Pre-Market Approval
FDA Class 3 ·NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·Progel Pleural Air Leak Sealant

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·Resolute Onyx Coronary Stent System

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS iTEC Preloaded Delivery System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Assurity MRI and Endurity MRI

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·Resolute Onyx Coronary Stent Systems

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·AFX ENDOVASCULAR AAA SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·PROMOTE MODELS 3207-36 AND 3207-30

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval
FDA Class 3 ·T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NEUROPACE RNS SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·ZYPLAST(R)

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MODEL 1210 OMNIPULSE(TM) HOLMIUM LASER SYSTEM

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP