SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK

FDA 510(k)

FDA Class 2 ·Ophthalmic

TIMX LOW BACK SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

VSP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

INDICATENS 4X4

FDA 510(k)

FDA Class 2 ·Neurology

OMNI OXYGEN SYSTEM, MODEL 1000

FDA 510(k)

FDA Class 2 ·Anesthesiology

INSUFFLATOR TUBING KIT W/FILTER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPECTROLYSE/FIBRIN

FDA 510(k)

FDA Class 2 ·Hematology

BINAXNOW INFLUENZA A & B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCES Z QUAD PLUS LEAD MODEL, 3892

FDA 510(k)

FDA Class 2 ·Neurology

FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LENSX LASER SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

Clavicle and Scapula System

FDA 510(k)

FDA Class 2 ·Orthopedic

BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

iC-GPC Assay TM for use on the iC-SystemTM

FDA 510(k)

FDA Class 2 ·Microbiology

CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196

FDA 510(k)

FDA Class 2 ·Immunology

AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA

FDA 510(k)

FDA Class 2 ·Immunology

Aptiva Celiac Disease IgG Reagent

FDA 510(k)

FDA Class 2 ·Immunology

BIB Stent Placement Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUANTA LITE CELIAC SCREEN (TISSUE TRANSGLUTAMINASE/GLIADIN) ELISA

FDA 510(k)

FDA Class 2 ·Immunology