61 results · 35ms · Sources: EU EUDAMED, US FDA

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·Rotlex IOLA MFD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·IDENTIFY, VERITY, VICTORY, ZEPHYR, ACCENT FAMILY OF DE PACERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·FLEXTOME CUTTING BALLOON MONORAIL

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·VASCULAR SOLUTIONS D-STAT FLOWABLE HEMOSTAT

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·NIRxcell CoCr Coronary Stent on RX System

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·Sientra OPUS Silicone Gel Breast Implants

Device, Vascular, For Promoting Embolization

FDA Pre-Market Approval
FDA Class 2 ·MINI BALLOON

Device, Vascular, For Promoting Embolization

FDA Pre-Market Approval
FDA Class 2 ·MINI BALLOON

Device, Vascular, For Promoting Embolization

FDA Pre-Market Approval
FDA Class 2 ·MINI BALLOON

Device, Vascular, For Promoting Embolization

FDA Pre-Market Approval
FDA Class 2 ·MINI-BALLOON DETACHABLE BALLOON SYSTEM

Saliva, Artificial

FDA Pre-Market Approval
FDA Unclassified ·SALIVART

Device, Vascular, For Promoting Embolization

FDA Pre-Market Approval
FDA Class 2 ·MINI BALLOON

Device, Vascular, For Promoting Embolization

FDA Pre-Market Approval
FDA Class 2 ·MINI BALLOON

Device, Vascular, For Promoting Embolization

FDA Pre-Market Approval
FDA Class 2 ·MINI BALLOON

Device, Vascular, For Promoting Embolization

FDA Pre-Market Approval
FDA Class 2 ·MINI BALLOON

Device, Vascular, For Promoting Embolization

FDA Pre-Market Approval
FDA Class 2 ·MINI BALLOON

Device, Vascular, For Promoting Embolization

FDA Pre-Market Approval
FDA Class 2 ·MINI BALLOON

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·Roche cobas EGFR Mutation Test, Roche cobas® DNA Sample Preparation Kit, cobas® EGFR Mutation Test v2, Roche cobas® cfD