ADVIA CENTAUR HOMOCYSTEINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA RETIC PLUS

FDA 510(k)

FDA Class 2 ·Hematology

CODETRON TRANSCUTANEOUS ELECTRICAL NERVE STIMULA.

FDA 510(k)

FDA Class 2 ·Neurology

CBC-SF

FDA 510(k)

FDA Class 2 ·Hematology

COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ADVIA 60 HEMATOLOGY ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

AVANTE Z; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN

FDA 510(k)

FDA Class 2 ·Dental

BRUKER R-28,HEAD AND CHEST ANGIOGRAPHY IMAGING ADD

FDA 510(k)

FDA Class 2 ·Radiology

ADD MIX ALLERGEN PANEL MOD ALASTAT(R) ALLERGEN IGE

FDA 510(k)

FDA Class 2 ·Immunology

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MICRO-PACE DUAL-CHAMBER, DDD, TEMPORARY CARDIAC PACEMAKER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS RX PERFUSION CORON. DILATION CATHETER ADD 2.0

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·O-PERM F60 RGP CONTACT LENS ADD FINISH LABS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OCUSIL(R) (NEFOCON A) CONTACT LENSES ADD FIN LABS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·O-PERM F60 RGP CONTACT LENS ADD FINISH LABS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·O-PERM F60 RGP CONTACT LENS ADD FINISH LABS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OCUSIL(R) (NEFOCON A) CONTACT LENSES ADD FIN LABS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OCUSIL(R) (NEFOCON A) CONTACT LENSES ADD FIN LABS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·O-PERM F60 RGP CONTACT LENS ADD FINISH LABS

Pulse-Generator, Pacemaker, External

FDA Pre-Market Approval

FDA Class 2 ·MODEL4553 MICRO-PACE,DUAL-CHAMBER,DDD TEMPORARY CARDIAC PACEMAKER