828 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·O2 OPTIX (LOTRAFILCON B) AND NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·Guardant360 CDx
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne Liquid CDx (F1 Liquid CDx)
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne Liquid CDx
Kit, Rna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·APTIMA HPV 16 18/45 GENOTYPE ASSAY
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ENDOTAK LEAD SYSTEM
Prosthesis, Ankle, Uncemented, Non-Constrained
FDA Pre-Market Approval
FDA Class 3
·Hintermann Series H3 Total Ankle Replacement System
Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
FDA classification
FDA Class 3
·Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated