123 results · 19ms · Sources: EU EUDAMED, US FDA

Intracranial Coil-Assist Stent

FDA Pre-Market Approval
FDA Class 3 ·Neuroform Atlas Stent System

Tympanostomy Tube Delivery Product With Drug

FDA Pre-Market Approval
FDA Class 3 ·Tula® System

Tympanostomy Tube Delivery Product With Drug

FDA Pre-Market Approval
FDA Class 3 ·Tula System

Intracranial Coil-Assist Stent

FDA Pre-Market Approval
FDA Class 3 ·Neuroform Atlas Stent System

Intracranial Coil-Assist Stent

FDA Pre-Market Approval
FDA Class 3 ·Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.

Intracranial Coil-Assist Stent

FDA Pre-Market Approval
FDA Class 3 ·Neuroform Atlas® Stent System

Intracranial Coil-Assist Stent

FDA Pre-Market Approval
FDA Class 3 ·Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.

Tympanostomy Tube Delivery Product With Drug

FDA Pre-Market Approval
FDA Class 3 ·Tula SystemTube Delivery System (TDS)

Intracranial Coil-Assist Stent

FDA Pre-Market Approval
FDA Class 3 ·Low-Profile Visualized Intraluminal Support (LVIS), LVIS Jr., LVIS EVO

Intracranial Coil-Assist Stent

FDA Pre-Market Approval
FDA Class 3 ·LVIS and LVIS Jr.

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·Promus Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System and Promus Premier Everolimus-Eluting Pla

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM AND PROMUS PREMIER EVEROLIMUS-ELUTING PLA

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·ORCHESTRA PROGRAMMER

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·ISOLINE 2CR DEFIBRILLATION LEADS

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval
FDA Class 3 ·QCELLUS LASER

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·Amplia MRI CRT-D/Amplia MRI Quad CRT-D/ Brava CRT-D/Claria Quad CRT-D/ Brava Quad CRT-D/ Compia MRI Quad CRT-D/ Viva Qua

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·QUANTITOPE 125I AFP KIT AND CONTROL SERUM

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·QUANTITOPE 125I AFP KIT AND CONTROL SERUM

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·AFP/OB(TM) RIA KIT

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·QUANTITOPE 125I AFP KIT AND CONTROL SERUM