10,000 results · 39ms · Sources: EU EUDAMED, US FDA

Scaffold, Dissection Repair

FDA Pre-Market Approval
FDA Class 3 ·Tack Endovascular System (4F)

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·INTACS PRESCRIPTION INSERTS

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·Pipeline™ Flex with Shield Technology™

Glenoid Fossa Prosthesis

FDA Pre-Market Approval
FDA Class 3 ·TMJ FOSSA EMINENCE/CONDYLAR PROSTHESIS SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE SP & CAPSURE Z

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOFINITY XR TORIC

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·GIANTURCO-ROUBIN FLEX STENT/GRII(TM) CORONARY STENT

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·ETHICON OMNEX SURGICAL SEALANT

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·V.1 2A PROGRAMMER SOFTWARE

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·TENDRILL PASSIVE PLUS/AU PLUS DX

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS GL65C-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VENTRITEX TUL LEAD SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC SPRINT MODELS 6943/6945

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval
FDA Class 3 ·ProCol Vascular Bioprosthesis

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC SPRINT TM MODEL 6932 LEAD

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·Hydrus Microstent

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·Axonics Sacral Neuromodulation System