4,124 results · 21ms · Sources: EU EUDAMED, US FDA

Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation

FDA Pre-Market Approval
FDA Class 3 ·PINNACLE COMPLETE ACETABULAR HIP SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·NAVISTAR RMT THERMOCOOL

System, Imaging, Fluorescence

FDA Pre-Market Approval
FDA Class 3 ·PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF RESTOR IQ IOL

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne CDx (F1CDx)

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·Pipeline™ Vantage Embolization Device with Shield Technology™ (Pipeline™ Vantage)

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·IMMULITE/IMMULITE 1000 AFP and IMMULITE 2000 AFP

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·BELOTERO BALANCE

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·SUPERA PERIPHERAL STENT SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval
FDA Class 3 ·VISULAS 690S AND VISULINK PDT/U ADAPTER

Catheter, Balloon, Transcervical

FDA Pre-Market Approval
FDA Class 3 ·GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ELASTIC LENS(TM) AA-4203 & CHIROFLEX(TM) 32-C10XX

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·REALIZE ADJUSTABLE GASTRIC BAND WITH INJECTION PORT & APPLIER

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·COLLAMER UV-ABSORBING POSTERIOR CHAMBER IOL

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·ReShape Integrated Dual Balloon System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Gore Tag Thoracic Endoprosthesis

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RHA®3 dermal filler

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·SOFLENS