35 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
·FRESHLOOK(TM) UV SPHERICAL (PHEMFILCON A) MOLDED SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR
Artificial Heart
FDA Pre-Market Approval
FDA Class 3
·SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)
Sealant, Dural
FDA Pre-Market Approval
FDA Class 3
·Adherus AutoSpray ET Dural Sealant, Adherus AutoSpray Dural Sealant
Sealant, Dural
FDA Pre-Market Approval
FDA Class 3
·Adherus AutoSpray Dural Sealant, Adherus ET AutoSpray Dural Sealant
Lens, Multifocal Intraocular
FDA Pre-Market Approval
FDA Class 3
·SBL-3 Intraocular Lens
Lens, Multifocal Intraocular
FDA Pre-Market Approval
FDA Class 3
·SBL-3 Multifocal Intraocular Lens
Lens, Multifocal Intraocular
FDA Pre-Market Approval
FDA Class 3
·SBL-3 Multifocal Intraocular Lens
Prosthesis, Finger, Constrained, Metal/Polymer
FDA Pre-Market Approval
FDA Class 3
·SBI BRAUN-CUTTER TRAPEZ-METACARPAL PROSTHESIS
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·COROX OTW (-S) BP STEROID-ELUTING LEADS
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·COROX OTW (-S) BP LEFT VENTRICULAR LEADS
System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
FDA Pre-Market Approval
FDA Class 3
·ColoSense®
System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
FDA Pre-Market Approval
FDA Class 3
·ColoSense
System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
FDA Pre-Market Approval
FDA Class 3
·ColoSense®
Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4
FDA Pre-Market Approval
FDA Class 3
·MAGE-A4 IHC 1F9 pharmDx
System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
FDA Pre-Market Approval
FDA Class 3
·ColoSense
Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4
FDA Pre-Market Approval
FDA Class 3
·MAGE-A4 IHC 1F9 pharmDx
System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
FDA Pre-Market Approval
FDA Class 3
·ColoSense
System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
FDA Pre-Market Approval
FDA Class 3
·ColoSense
Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4
FDA Pre-Market Approval
FDA Class 3
·MAGE-A4 IHC 1F9 pharmDx
System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
FDA Pre-Market Approval
FDA Class 3
·ColoSense®