4,124 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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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