System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·VISULAS 690S AND VISULINK PDT/U ADAPTER

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·COHERENT OPAL PHOTOACTIVATOR

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·CERALAS I LASER

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·QUANTEL ACTIVIS LASER AND ZSL30 ACT, ZSL120 ACT, AND HSBMBQ ACT SLIT LAMP ADAPTERS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·NIGHT & DAY 30 NIGHT EXTENDED WEAR SOFT CONTACT LENS

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS

Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

FDA Pre-Market Approval

FDA Class 3 ·DAKO TOP2A FISH PHARMDX KIT

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·VISULAS 690 PLUS LASER & VISULINK PDT/U ADAPTER

Glenoid Fossa Prosthesis

FDA Pre-Market Approval

FDA Class 3 ·TMJ FOSSA-EMINENCE PROSTHESIS(TM)

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESES

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·ONCOR(R) AMPLITECT(TM) HER/NEU(ERBB2)GENE AMPLIFI

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ACS 180/ADVIA CENTAUR AFP IMMUNOASSAY

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval

FDA Class 3 ·VENTANA ALK (D5F3) CDx Assay

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS KRAS MUTATION TEST

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·COLOGUARD