1,723 results · 19ms · Sources: EU EUDAMED, US FDA

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·ADATO SIL-O1 5000 SILICONE OIL

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·ADATO SIL-OL 5000 SILICONE OIL

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·ADATO SIL-OL 5000 SILICONE OIL

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·ADATO SIL-OL 5000 SILICONE OIL

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·ADATO SIL-OL 5000 SILICONE OIL

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·ADATO Sil-Ol 5000 Silicone Oil

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval
FDA Class 3 ·PRISMAFLEX TPE 2000 WITH PLASMAFILTER PF2000N

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·SILIKON 1000

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·LCS COMPLETE TOTAL KNEE SYSTEM

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·Hydrus Microstent

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·Cobas EGFR MUTATION TEST v2

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas EGFR Mutation Test and cobas® EGFR Mutation Test, v2

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·COBAS KRAS MUTATION TEST

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·CERAMIC TRANSCEND HIP ARTICULATION SYSTEM

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·MFK IOL

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·HQL Softec HD, Softec I, Softec HD PS, Softec HDO, Softec HDM

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval
FDA Class 3 ·TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM

Joint, Temporomandibular, Implant

FDA Pre-Market Approval
FDA Class 3 ·TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartWare Ventricular Assist System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Precision Spinal Cord Stimulator (SCS)System