Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MAXIMO VR MODELS 7232B AND 7232 IMPLANTABLE CARDIAC DEFIBRILLATORS (ICDS)

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ACCESS AFB REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

Femtosecond Laser System For Refractive Correction

FDA Pre-Market Approval

FDA Class 3 ·VisuMax Femtosecond Laser

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS PC-43,44,45 NB UV ABSORBING IOL

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT (ABI)

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·B.BRAUN,S HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P) SYSTEM

FDA Pre-Market Approval

GEN-PROBE(R) AMPLIFIED(TM) MYCOBACTERIUM TUBERCULOSIS DIRECT (MTD) TEST

Implant, Auditory Brainstem

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval

FDA Class 3 ·LINX Reflux Management System

Implant, Auditory Brainstem

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·LOGICON CARIES DETECTOR

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)