Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ORTHOLOGIC 1000 SC

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·FRONTIER/FRONTIER II CRT-P

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM: CARELINK PRO, MMT-7335 VERSION 3.0B

Stent, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval

FDA Class 3 ·Zilver PTX Drug-Eluting Peripheral Stent

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·EON MINI LE CHARGING SYSTEM AND PRODIGY CHARGER SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ENDOLOGIX POWERLINK SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·REVEAL DX. REVEAL XT, REVEAL LINQ INSERTABLE CARDIAC MONITOR

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADARVISION 4000 AND LADAR6000 EXCIMER LASER SYSTEMS AND THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE

Instrument, Glucose, Noninvasive Technology

FDA Pre-Market Approval

FDA Class 3 ·GLUCOWATCH G2 BIOGRAPHER

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

FDA Pre-Market Approval

FDA Class 3 ·MetriQ Irrigation Tubing Set

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Revo MRI SureScan IPG

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ventak AV Aicd Ventak Prizm DR/VR, Vitality, Cofient and Teligen Automatic Implantable Cardiovetr Defibrillator System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·CYPHER SIROLIMUS CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER STENT

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·Cologuard®

P2psa

FDA Pre-Market Approval

FDA Class 3 ·Access Hybritech p2PSA Reagents on the Access Immunoassay Systems

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

FDA Pre-Market Approval

FDA Class 3 ·ACUITY X4 lead family shelf life

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·ALLEGRETTO WAVE EXCIMER LASER SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·CONCERTO MODELS C154DWK / C164AWK CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE VDD-2 LEAD

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·RX ACCULINK CAROTID STENT SYSTEM