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

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·VISX STAR S4 IR EXCIMER LASER SYSTEM AND WAVESCAN SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·VISX STAR S2 EXCIMER LASER SYSTEM

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval
FDA Class 3 ·THERAKOS® CELLEX® Photopheresis System Procedural Kit

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·The SENSAR 1-Piece IOL with SmartLOAD Delivery Technology, The TECNIS 1-Piece IOL with SmartLOAD Delivery Technology, Th

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·AMO CLARIFLEX INTRAOCULAR LENSES (IOL) ( MODELS CLRFLX/CLRFLXB/CLRFLXC) & TECNIS CL 3-PIECE INTRAOCULAR LENS (IOL)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·HEALON D

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS Symfony Toric Extended Range of Vision IOL and TECNIS Toric 1-Piece IOL

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·AMO SENSAR SOFT ACRYLIC INTRAOCULAR LENSES (IOL) (MODELS AR40E/AR40E/AR40M/AR40MN) & TECNIS 1 PIECE INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS IOLs

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IMG, Astra S DR MRI IG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra X

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·VIDAS TOTAL PSA

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THxID BRAF assay kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THXID BRAF KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THXID™-BRAF

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·VIDAS FREE PSA RT ASSAY

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·VIDAS TOTAL PSA ASSAY

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THxID BRAF assay kit

System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·ColoSense®

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·VIDAS TOTAL PSA