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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR HBSAG READYPACK REAGENTS / CONFIRMATORY ASSAY/ QUALITY CONTROL MATERIAL

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MICRONY PACEMAKERS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Bausch + Lomb Ultra (samfilcon A) Contact Lenses

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·META AND TEMPO PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PARAGON,PHOENIX, MULTILOG, AND SENSORITHM PACEMAKERS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·AURORA/QUADRA, REFLEX, SIMPLEX,META PACEMAKERS

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

FDA Pre-Market Approval

FDA Class 3 ·FRONTIER AND FRONTIER II BIVENTRICULAR PACING SYSTEMS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·EPIC II VR, EPIC II DR, AND EPIC II+ DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·REGENCY, SENSOLOG III, DIALOG II PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SELECT MODELS OF SYNCHRONY, TRILOGY AND AFFINITY FAMILY OF PACEMAKERS, SOLUS,ADDVENT, SOLUS II, SYNCHRONY,PHOENIX III, Y

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

FDA Pre-Market Approval

FDA Class 3 ·EPIC II HF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (MODEL V-355) AND MODEL 3307 V.6.0M SOFTWARE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PHILOS II DR, PHILOS II D, PHILOS II DR-T, PHILOS II SLR, PHILOS II SR, PHILOS II S, AND PROGRAMMER SOFTWARE VERSION A-U

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOFINITY (COMFILCON A)

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·CERVISTA HPV HR HIGH-THROUGHPUT AUTOMATION

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ACS AND ACS RX MULTI-LINK CORONARY STENT SYSTEMS