23 results · 23ms · Sources: EU EUDAMED, US FDA

Implant, Auditory Brainstem

FDA Pre-Market Approval
FDA Class 3 ·Nucleus AB1541 Auditory Brainstem Implant

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·Nucleus 24 Cochlear Implant System

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval
FDA Class 3 ·Nucleus Hybrid Cochlear Implant System

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·SBL-3 Intraocular Lens

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)

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

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·Adherus AutoSpray ET Dural Sealant, Adherus AutoSpray Dural Sealant

Prosthesis, Finger, Constrained, Metal/Polymer

FDA Pre-Market Approval
FDA Class 3 ·SBI BRAUN-CUTTER TRAPEZ-METACARPAL PROSTHESIS

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·Adherus AutoSpray Dural Sealant, Adherus ET AutoSpray Dural Sealant

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS KRO,KR10,KBO,KB10,OF10,OB10,KN10,NB10 LENS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS KRO,KR10,KBO,KB10,OF10,OB10,KN10,NB10 LENS

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