Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·Wolverine Coronary Cutting Balloon

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·COLLASTAT HEMO SPONGE CHANGE IN PACKAGING

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER OPEN-IRRIGATED ABLATION CATHETER

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PRIZM HE/3/VITALITY/2/AVT/CONFIENT/TELIGEN

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTEC HD,SOFTEC I,SOFTEC HD PS AND SOFTEC HDO

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Softec HD/ HD PS, Softec I, Softec HDO, Softec HDM IOLs

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTEC HD, SOFTEC HD PS, SOFTEC I AND SOFTEC HDO DEVICES.

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Softec HD, Sotlec I, Softec HD PS, Softec HDO, Softec HDM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTEC HD; SOFTEC I; SOFTEC HD PS AND SOFTEC HDO IOLS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·BIPOLAR ENDOCARDIAL LEADS 0012/0013 BIPOLAR ENDOCARDIAL LEADS & POSITIVE FIXATION PROTECTED-HELIX BIPOLAR ENDOCAR. LEAD

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·HQL Softec HD, Softec I, Softec HD PS, Softec HDO, Softec HDM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs

Device, Testicular Hypothermia

FDA Pre-Market Approval

FDA Class 3 ·REPRO-MED - THD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL/3/3 HE/3 RF/LIVIAN RF1 SE/CONTAK RENEWAL 3 AVT/COGNIS

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·HERCEP TEST

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·DAKOCYTOMATION HERCEP TEST