35 results · 19ms · Sources: EU EUDAMED, US FDA

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®