Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·DURALOC OPTION CERAMIC ON CERAMIC HIP SYSTEM

Telescope, Implantable, Miniature

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE (IMT) MODELS WIDE ANGLE 2.2X & WIDE ANGLE2.7X

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·iSert Preloaded System, iSpheric, iSymm IOL Models, Clarisert Preloaded System

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval

FDA Class 3 ·Optune System

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

FDA Pre-Market Approval

FDA Class 3 ·MONOLISA ANTI-HBC IGM EIA

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

FDA Pre-Market Approval

FDA Class 3 ·MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT

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

FDA Pre-Market Approval

FDA Class 3 ·MONOLISA ANTI-HBC EIA

Diagnostic Low Electric Field

FDA Pre-Market Approval

FDA Class 3 ·MARGINPROBE SYSTEM

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval

FDA Class 3 ·Optune Gio

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval

FDA Class 3 ·Optune Gio

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval

FDA Class 3 ·Optune Gio

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval

FDA Class 3 ·Optune Gio

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·BIO OSTEOGEN SYSTEM

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval

FDA Class 3 ·Optune® Gio

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·S.M.A.R.T NITINOL STENT SYSTEM & CONTROL NITINOL STENT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBC EIA

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·BIO OSTEOGEN SYSTEM 204

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·BIO OSTEOGEN SYSTEM 204

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·BIO OSTEOGEN SYSTEM 204

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·BIO OSTEOGEN SYSTEM 204