1,463 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER 1-PC AND 3-PC INTRAOCULAR LENSES
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Senza Spinal Cord Stimulation (SCS) Systems
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·Single-Piece PMMA Posterior Chamber IOL
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·Single-Piece PMMA Anterior Chamber IOLs
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Senza Spinal Cord Stimulation (SCS) System and HFX iQ System
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Senza Spinal Cord Stimulation (SCS) System
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Senza Spinal Cord Stimulation (SCS) System
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ENPULSE E1 IPG, ENPULSE E2 IPG,KAPPA D (KAPPA 700) IPG, KAP
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA DR MRI IPG,AT500 DDDRP PACING SYSTEM IPG, ENPULSE E2 IPG,ENPULSE E2 IPG,KAP
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ENTRUST ICD,INTRINSIC 30 ICD, INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD, KAPPA DR(KAPPA 700/600)IPG, KAP
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·NIDEK EXCLAIMER LASER SYSTEM EC-5000
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·Astra S DR MRI, Astra S SR MRI, Astra XT DR MRI, Astra XT SR MRI, Azure S DR MRI, Azure S SR MRI, Azure XT DR MRI and Az
THERMAL DIFFUSION CEREBRAL BLOOD FLOW MONITOR
FDA 510(k)
FDA Class 3
·Unknown
Stent, Iliac Vein
FDA Pre-Market Approval
FDA Class 3
·Venovo Venous Stent System
Stent, Superficial Femoral Artery
FDA Pre-Market Approval
FDA Class 3
·GORE TIGIRIS Vascular Stent
Stent, Superficial Femoral Artery
FDA Pre-Market Approval
FDA Class 3
·LifeStent Vascular Stent Systems
Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
FDA Pre-Market Approval
FDA Class 3
·VENTANA ALK (D5F3) CDx Assay
Immunohistochemistry Antibody Assay, C-Kit
FDA Pre-Market Approval
FDA Class 3
·PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY
Stent, Superficial Femoral Artery
FDA Pre-Market Approval
FDA Class 3
·GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface
Stent, Superficial Femoral Artery
FDA Pre-Market Approval
FDA Class 3
·GORE TIGRIS Vascular Stent