Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·ACUVUE 2 COLOURS (TM) BRAND (ETALFILCON A) CONTACT LENS WITH UV BLOCKER

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ANTERIOR CHAMBER INTRAOCULAR LENS (CATARACT)

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·FOCALPOINT SYSTEMCREENING SYSTEM

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·AUTOPAP PRIMARY SCREENING SYSTEM

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MEDICAL SYSTEMS PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY

Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5) PRIMARY ANTIBODY

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT ARCHITECT AUSAB

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) TRANSVENE LEAD SYSTEM

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT AUSAB, ARCHITECT I1000 SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Nucleus 24 Cochlear Implant System

Electrical Impedance Spectrometer

FDA classification

FDA Class 3 ·Electrical Impedance Spectrometer

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) CONTACT LENS MATERIAL

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOFINITY (COMFILCON A)

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA classification

FDA Class 3 ·System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Condom, Female, Animal Tissue

FDA classification

FDA Class 3 ·Condom, Female, Animal Tissue