10,000 results
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58ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR HBCIGM
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ENRHYTHM IPG
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·CEEON ULTRAVIOLET LIGHT-ABSORBING POLYMETHYLMETHACRYLATE (PMMA) POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·ATTAIN BIPOLAR OTW LEAD,CONSULTA CRT-P,LEFT VENTRICULAR PACING LEAD,SYNCRA CRT-P
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·VERIFLEX (LIBERTE) CORONARY STENT SYSTEM
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·ATTAIN ABILITY LEAD
Stent, Renal
FDA Pre-Market Approval
FDA Class 3
·EXPRESS SD RENAL PREMOUNTED STENT SYSTEM
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·RADIESSE INJECTABLE IMPLANT
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·Oncomine Dx Target Test
Stent, Carotid
FDA Pre-Market Approval
FDA Class 3
·Cordis® PRECISE® Nitinol Stent System
Agent, Bulking, Injectable For Gastro-Urology Use
FDA Pre-Market Approval
FDA Class 3
·Coaptite Injectable Implant
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·REBEL Platinum Chromium Coronary Stent System
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·TECNIS Simplicity Delivery System
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, SPhera DR MRI IPG, and Sphera SR MRI IPG
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
FDA Pre-Market Approval
FDA Class 3
·WOLVERINE Coronary Cutting Balloon
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·GELSYN-3
Lipoprotein, Low Density, Removal
FDA Pre-Market Approval
FDA Class 3
·Heparin_Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·CapSure Sense Lead