Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

FDA Pre-Market Approval

FDA Class 3 ·DAKO EGFR PHARMDX KIT

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·PHYSIO-STIM BONE GROWTH STIMULATOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RIATA ST OPTIM LEADS AND RIATA STS OPTIM LEADS AND

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

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

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·STRAUMANN EMDOGAIN

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·CONTINUOUS GLUCOSE MONITORING SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·PATH VYSION HER-2 DNA PROBE KIT

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME REVEL SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLATFORM

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 530G SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDSTREAM AND CODMAN 3000 IMPLANTABLE INFUSION PUMP

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·LINOX(SMART) S DX STEROID-ELUTING SINGLE-COIL ICD LEADS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL SOFT HYDROPHILIC CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·GENTLE TOUCH UV (NETRAFILCON) SOFT CONTACT LENSES

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·EMDOGAIN

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANT

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS ONE-PIECE INTRAOCULAR LENS, MODEL ZCB00