Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·HYALGAN

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK CALIBRATOR

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·ENLITE GLUCOSE SENSOR

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System (Bowel)

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System (Urinary)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 2490D CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR ENPULSE MODELS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG Thoracic Endoprosthesis and GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER Iliac Branch Endoprosthesis

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 2490D CARELINK MONITOR

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·HERCEP TEST

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·HER2 CISH PHARMDX KIT

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·HER2 IQFISH PHARMDX

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·COMBI 40+COCHLEAR IMPLANT SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYNERGYST II PULSE GENERATOR

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 2490D/E CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR INSYNC ICD, MODEL 7272 AND INSYNC MARQUIS, M

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM - PFC SIGMA RPF KNEE SYSTEM