Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME REVEL SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS

System, Laser, Fiber Optic, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·OPTIGUIDE FIBER OPTIC DIFFUSER (DCYL CYLINDRICAL DIFFUSER SERIES)

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS AMPLIPREP/COBAS TAQMAN HBV TEST

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Aptima HBV Quant Assay

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOFINITY ENERGYS ASPHERE, BIOFINITY XR TORIC, BIOFINITY XR MULTIFOCAL

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) TRANSVENE LEAD SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND QAULITY CONTROL MATERIAL

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·APTIMA HPV ASSAY

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval

FDA Class 3 ·BAYER IMMUNO 1 COMPLEXED PSA ASSAY

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·Multi-Target Stool DNA (mtsDNA) Test, Cologuard Plus™

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORETEC HEARTMATE XVE LVAS

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM (SNAP VE LVAS)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartStart FRx Defibrillator

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·OL1000, OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK(TM)

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES