10,000 results · 44ms · Sources: EU EUDAMED, US FDA

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER SEPTAL OCCLUDER

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·IC-8 Apthera Intraocular Lens (IOL)

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·SPHINCTER 800 URINARY CONTROL SYSTEM

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·LUTONIX DRUG COATED BALLOON PTA CATHETER

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

FDA Pre-Market Approval
FDA Class 3 ·AXSYM AUSAB

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·DURASEAL EXACT SPINE SEALANT SYSTEM

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·FALOPE RING BAND AND APPLICATOR SYSTEMS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·AIR OPTIX FOR ASTIGMATISM

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·BD PREPSTAIN SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOFINITY XR

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Pre-Market Approval
FDA Class 3 ·ESTEEM

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·Raindrop Near Vision Inlay

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·G5 Mobile Continuous Glucose Monitoring System

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·coflex Interlaminar Stabilization Device

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Zenith Dissection Endovascular System

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·NEOMEND'S PROGEL PLEURAL AIR LEAK SEALANT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CADENCE/CADET/CONTOUR/II/MD/ATLAS II/MD/+/PROFILE II/MD/PHOTON/PHOTON MICRO/CURRENT/+/EPIC II/+/CONVERT

Lens, Intraocular, Phakic

FDA Pre-Market Approval
FDA Class 3 ·EVO/EVO+ VISIAN® Implantable Collamer® Lenses

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE® EXCLUDER® Conformable AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis