Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System and Verify Evaluation System (SNS Bowel)

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval

FDA Class 3 ·PORT-A-CATH EPIDURAL & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·OCUSIL(R) (NEFOCON A) CONTACT LENSES ADD FIN LABS

Applicator, Hyperthermia, Deep Heating, Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM

Applicator, Hyperthermia, Deep Heating, Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM

Applicator, Hyperthermia, Deep Heating, Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM

Gonococcal Antibody Tests

FDA Pre-Market Approval

FDA Class 3 ·FLUORESCENT GONORRHEA TEST-HEATED (FGT-H)

LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES

FDA 510(k)

FDA Class 3 ·Cardiovascular

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER LA-15 SYSTEM

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·Liposorber LA-15 System

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER LA-15 SYSTEM

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER LA-15 System

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·PLASMAT SECURA HEPARIN-INDUCED EXTRACORPOREAL LDL APHERESIS SYSTEM (H.E.L.P.)

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

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

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER LA-15 System

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER LA-15 System

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·H.E.L.P. Futura Apheresis System

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER(R) LA-15 SYSTEM

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER(R) LA-15 SYSTEM

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·BLOOD TUBING SYSTEM FOR THE LIPOSORBER LA-15 SYSTEM