Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS EGFR MUTATION TEST V2

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·MENICON Z(TM) (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR 30-DAY EXTENDED WEAR

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IC-8 Apthera Intraocular Lens (IOL)

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS

Cap, Cooling (Infants)

FDA classification

FDA Class 3 ·Cap, Cooling (Infants)

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

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

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·INSPIRE II UPPER AIRWAY STIMULATOR

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THERASCEEN EGFR RGQ PCR KIT

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFLENS (POLYMACON) CONTACT LENSES

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

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

Nitric Oxide Generator And Delivery System

FDA classification

FDA Class 3 ·Nitric Oxide Generator And Delivery System

Cultured Human Cell Skin Dressing

FDA classification

FDA Class 3 ·Cultured Human Cell Skin Dressing

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC TEST SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC TEST SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITUOSO DR, VIRTUOSO VR, VIRTUOSO II DR, VIRTUOSO II VR, SECURA DR, SECURA VR, PROTECTA XT DR, PROTECTA XT VR

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED II PROGRAMMABLE PUMP

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC