2,355 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·THINPREP(R) PROCESSOR
Tissue Graft Of 6mm And Greater
FDA Pre-Market Approval
FDA Class 3
·Artegraft Collagen Vascular Graft
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·AUTODELFIA HAFP TEST SYSTEM
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·THINPREP SLIDES
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS 700 INFLATABLE PENILE PROSTHESIS
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·MENICON SF-P (MELAFOCON A) CONTACT LENS
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·ThinPrep Genesis Processor
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·PREVELLE SILK
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·IMPELLA 2.5 SYSTEM
Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
FDA Pre-Market Approval
FDA Class 3
·PROSORBA COLUMN
Device, Thermal Ablation, Endometrial
FDA Pre-Market Approval
FDA Class 3
·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·APLIGRAF (GRAFTSKIN)
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne Liquid CDx (F1LCDx)
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·IMPELLA 2.5 SYSTEM
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·Axonics Sacral Neuromodulation System
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·THINPREP PROCESSORS
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·oncoRevealTM CDx