876 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS PLATFORM
Continuous Glucose Monitor, Implanted, Adjunctive Use
FDA Pre-Market Approval
FDA Class 3
·Eversense Continuous Glucose Monitoring System
Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
FDA Pre-Market Approval
FDA Class 3
·QUANTIFERON -TB GOLD
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·HCS HPV, HCII HPV
Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
FDA Pre-Market Approval
FDA Class 3
·QUANTIFERON-TB
Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
FDA Pre-Market Approval
FDA Class 3
·QuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·BD Onclarity HPV Assay
Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
FDA Pre-Market Approval
FDA Class 3
·QUANTIFERON-TB GOLD IN-TUBE
Sensor, Glucose, Implanted, Non-Adjunctive Use
FDA Pre-Market Approval
FDA Class 3
·Eversense E3 CGM System
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·Angio Seal Vascular Closure Devices
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE
Continuous Glucose Monitor, Implanted, Adjunctive Use
FDA Pre-Market Approval
FDA Class 3
·Eversense Continuous Glucose Monitoring System
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·Oncomine Dx Express Test
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TESTS
Placental Alpha Microglobulin-1 Immunoassay
FDA Pre-Market Approval
FDA Class 3
·PartoSure Test
Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
FDA Pre-Market Approval
FDA Class 3
·Quantiferon TB Gold
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & DIGENE HYBRID CAPTURE 2 (HC2) HIGH RISK HPV DNA TEST
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·digene HC2 High-Risk HPV DNA Test and digene HC2 HPV DNA Test
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·HYBRID CAPTURE(TM) SYSTEM HPV DNA ASSAY