Catheter, Percutaneous (Valvuloplasty)

FDA Pre-Market Approval

FDA Class 3 ·Toray Inoue Balloon Catheter

Catheter, Percutaneous (Valvuloplasty)

FDA Pre-Market Approval

FDA Class 3 ·Inoue-Balloon Catheter

Catheter, Percutaneous (Valvuloplasty)

FDA Pre-Market Approval

FDA Class 3 ·TORAY INOUE BALLOON CATHETER

Catheter, Percutaneous (Valvuloplasty)

FDA Pre-Market Approval

FDA Class 3 ·Inoue Balloon Catheter

Catheter, Percutaneous (Valvuloplasty)

FDA Pre-Market Approval

FDA Class 3 ·INOUE BALLOON CATHETER

Catheter, Percutaneous (Valvuloplasty)

FDA Pre-Market Approval

FDA Class 3 ·INOUE BALLOON CATHETER

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Intraocular Lenses (IOLs) in the DaisyWheel and TECNIS SIMPLICITY Delivery System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Family of 1-piece IOLs packaged in the Daisy Wheel Configuration

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·ALERE NMP22 BLADDERCHECK TEST & CONTROL KIT

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·Alere NMP22 BladderChek Test

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·Alere NMP22 BladderChek Test

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·Scandinavian Total Ankle Replacement (S.T.A.R. Ankle)

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·UroVysion Bladder Cancer Kit

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE)

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·NMP22 ELISA TEST KIT

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·ALERE NMP22(TM) TEST

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·STAR PSI System

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·Scandinavian Total Ankle Replacement System (S.T.A.R. Ankle)

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·S.T.A.R Ankle System