158 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·ANCURE SYSTEM
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·Sientra Silicone Gel Breast Implants
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne Liquid CDx (F1LCDx)
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODIFIED J & C LOOP MODEL PA36
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·Oncomine Dx Target Test
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·TECNIS TORIC CALCULATOR
Wearable Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·LIFEVEST WEARABLE DEFIBRILLATOR
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Saluda Medical Evoke SCS System
Stent, Renal
FDA Pre-Market Approval
FDA Class 3
·CORDIS PALMAZ(R) BALLOON-EXPANDABLE STENT
Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation
FDA Pre-Market Approval
FDA Class 3
·Vivistim® System
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne CDx (FICDx)
Filler, Bone Void, Synthetic Peptide
FDA Pre-Market Approval
FDA Class 3
·i-FACTOR® Peptide Enhanced Bone Graft
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·Organ Care System (OCS®) Liver
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne CDx (F1CDx)
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne Liquid CDx (F1 Liquid CDx)
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·HIRESOLUTION BIONIC EAR SYSTEM
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·ACS MULTI-LINK CORONARY STENT SYSTEMS
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·THINPREP 2000 SYSTEM
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·BLAZER OPEN-IRRIGATED ABLATION CATHETER
Permanent Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS