29 results · 18ms · Sources: EU EUDAMED, US FDA

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·COOLFLOW TUBING IFU

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·STARCLOSE SE VASCULAR CLOSURE SYSTEM IFU

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 22 COCHLEAR IMPLANT SYSTEM (CHILDREN)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 22 COCHLEAR IMPLANT SYSTEM (ADULTS)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·IF4 BOARD FOR THE DUAL PROCESSOR INTERFACE SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·IF4 BOARD FOR THE DUAL PROCESSOR INTERFACE SYSTEM

Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

FDA Pre-Market Approval
FDA Class 3 ·T-SPOT. TB TEST

Ophthalmic Sealant

FDA Pre-Market Approval
FDA Class 3 ·RESURE SEALANT

Ophthalmic Sealant

FDA Pre-Market Approval
FDA Class 3 ·RESURE SEALANT

Ophthalmic Sealant

FDA Pre-Market Approval
FDA Class 3 ·Resure Sealant

Ophthalmic Sealant

FDA Pre-Market Approval
FDA Class 3 ·ReSure Sealant

Ophthalmic Sealant

FDA Pre-Market Approval
FDA Class 3 ·RESURE SEALANT

Ophthalmic Sealant

FDA Pre-Market Approval
FDA Class 3 ·RESURE SEALANT

Ophthalmic Sealant

FDA Pre-Market Approval
FDA Class 3 ·ReSure Sealant

Ophthalmic Sealant

FDA Pre-Market Approval
FDA Class 3 ·RESURE SEALANT

Ophthalmic Sealant

FDA Pre-Market Approval
FDA Class 3 ·ReSure Sealant

Ophthalmic Sealant

FDA Pre-Market Approval
FDA Class 3 ·ReSure Sealant

Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

FDA Pre-Market Approval
FDA Class 3 ·T SPOT-TB TEST