Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STYLE UV40 POSTERIOR CHAMBER LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL U58OH POSTERIOR CHAMBER LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STYLE UV40 POSTERIOR CHAMBER LENS

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·H.E.L.P. PLASMAT FUTURA 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 ·H.E.L.P. 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 LDL PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM

Imager, Breast, Electrical Impedance

FDA Pre-Market Approval

FDA Class 3 ·T-SCAN 2000

Imager, Breast, Electrical Impedance

FDA Pre-Market Approval

FDA Class 3 ·TS2000

Imager, Breast, Electrical Impedance

FDA Pre-Market Approval

FDA Class 3 ·TRANSCAN T-SCAN 2000

Ring, Endocapsular

FDA Pre-Market Approval

FDA Class 3 ·MORCHER CAPSULAR TENSION RINGS

KODAK T-MAT C FILM SO-119

FDA 510(k)

FDA Class 3 ·Unknown

KODAK T-MAT H FILM SO-118

FDA 510(k)

FDA Class 3 ·Unknown

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·RITHRON-XR CORONARY STENT SYSTEM

P.F.C. APICAL PLUG

FDA 510(k)

FDA Class 3 ·Orthopedic

JOINT MEASUREMENT INDICATOR

FDA 510(k)

FDA Class 3 ·Orthopedic

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (senofilcon A) Brand Contact Lenses

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) BRAND CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (senofilcon A) Brand Contact Lenses