10,000 results · 36ms · Sources: EU EUDAMED, US FDA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Durata and Optisure

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL 120UV ANTERIOR CHAMBER INTRAOCULAR LENS

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CPI SWITCH BOX

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL BALLOON CATHETER

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·PERMALENS (PERFILCON A)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CEEON HEPARIN SURFACE MODIFIED UV-LIGHT ABSORBING ANTERIOR CHAMBER (IOLS)

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS 019B, 019C, 019E, 019F, 019J, & 019K

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·Mentor MemoryShape Silicone Gel-Filled Breast Implants

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·TEMPO VR 1102 AND TEMPO V 1902

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORNARY STENT SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT MITRA & AORTIC,THEON,RSR,THEON RSR,MAGNA,MAGNA EASE WITH& WITHOUT THERMAFEX TISSUE PROCESS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·AMO SILICONE MONOFOCAL AND MULTIFOCAL INTRAOCULAR LENS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ELLIPSE/FORTIFY ASSURA FAMILY OF ICDS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY SYSTEM (RX AND OTW)

Aid, Surgical, Viscoelastic

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

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK APICAL LEFT VENTRICLE CONNECTOR

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·STYLE 17 & 17A POSTERIOR CHAMBER IOLS