10,000 results · 41ms · Sources: EU EUDAMED, US FDA

Sensor, Glucose, Invasive

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

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval
FDA Class 3 ·Mentor Spectrum Breast Implants, Mentor Saline-Filled Breast Implants

Valve, Pulmonary

FDA Pre-Market Approval
FDA Class 3 ·Zephyr Endobronchial Valve (EBV) System

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 670G System and MiniMed 770G System

Coronary Drug-Eluting Stent

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

Sealant, Polymerizing

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

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM G4 PLATINUM RECEIVER, G4 PLATINUM PEDIATRIC RECEIVER, DEXCOM G5 MOBILE RECEIVER, DEXCOM G4 PLATINUM RECEIVER WIT

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Edwards Sapien 3 Transcatheter Heart Valve

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Avalus

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Juvederm injectable Gel Implants

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOFINITY (COMFILCON A)

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Hancock II Bioprosthesis

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·cobas® HBV

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Edwards SAPIEN XT Transcatheter Heart Valve

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOFINITY (COMFILCON A)

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·SEN-SERTER, MODEL: MMT-7500

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS 1-PIECE IOL MODEL ZCB00

Pulse Generator, Permanent, Implantable

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

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOFINITY ENERGY ASPHERE