10,000 results · 30ms · Sources: EU EUDAMED, US FDA

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Guardian Connect system

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS PC10 & PC21

Intraocular Lens

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

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·iSert Preloaded IOL System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ICD FAMILY OF DEVICES & FORTIFY FAMILY OF DEVICES

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK II BIOPROSTHESIS, MODELS T505 AND T510

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·TRANSCYTE

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval
FDA Class 3 ·MICRONY PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·HOUSECALL PLUS SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MULTILINK ZETA CORONARY STENT SYSTEMS

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·AUTIMA(TM) MODEL 2251 & MODEL 2600

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·COMPLETE SE VASCULAR STENT SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE GENERATOR AND PROGRAMMER SOFTWARE MODEL 3307, V2.2A

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·CUSTOM TINTED HYDROCURVE II HYDROCURVE II APHAKIC, SOFTMATE II AND HC3 TORIC (BUFILCON A)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Tecnis 3-piece Acrylic Monofocal

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Juvéderm Ultra, Ultra XC, and Ultra Plus XC, Juvéderm Ultra XC

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MICRONY FAMILY OF PACEMAKERS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Lead Cap (IS-1/DF-1/SJ4/DF/IS4) IS4/DF4 Port Plug; DF-1 Receptacle Plug; IS-1 Receptacle Plug

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Cobas HBV