10,000 results · 47ms · Sources: EU EUDAMED, US FDA

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CT LUCIA 202 IOL and CT LUCIA 602 IOL

Aortic Valve, Prosthesis, Percutaneously Delivered

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

Stent, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval
FDA Class 3 ·ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·RX HERCULINK ELITE RENAL STENT SYSTEM

System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·ColoSense®

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·SJM MODEL 3510 PROGRAMMER(FOR ATLAS II CRT-D)/MERLIN MODEL 3650 PROGRAMMER( FOR ATLAS II & PROMOTE CRT-D)

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC IGM

Coronary Drug-Eluting Stent

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC REMOTE HOME MONITOR

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC HALL PROSTHETIC HEART VALVE /HALL EASY FIT

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·FEMCARE FILSHIE CLIP SYSTEM

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·ADIANA PERMANENT CONTRACEPTION SYSTEM

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·VNS THERAPY SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·CERAMAX CERAMIC TOTAL HIP SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·RIATA/RIATA ST/RIATA ST OPTIM/DURATA

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval
FDA Class 3 ·Scandinavian Total Ankle Replacement (STAR)

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT FREE PSA

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·TENDRIL/TENDRIL ST & STS/OPTISENSE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·COOPERVISION COMFILCON A SOFT EXTENDED WEAR CONTACT LENSES

Scaffold, Infrapopliteal, Absorbable

FDA Pre-Market Approval
FDA Class 3 ·Esprit™ BTK Everolimus Eluting Resorbable Scaffold System