FLIPSCREEN (TM) TOTAL E IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

VALIDATE Heparin Calibration Verification/Linearity Test Kit

FDA 510(k)

FDA Class 2 ·Hematology

EZTEST-STEAM

FDA 510(k)

FDA Class 2 ·General Hospital

EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120

FDA 510(k)

FDA Class 2 ·General Hospital

BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX

FDA 510(k)

FDA Class 2 ·Microbiology

VENTREX ALLERGEN DISC

FDA 510(k)

FDA Class 2 ·Immunology

BINAXNOW INFLUENZA A & B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

PROLITE III TOWER AND PR AND HR HANDPIECE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

X-spine Cortical Bone Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

Cortera™ Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES

FDA 510(k)

FDA Class 2 ·Hematology

MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012

FDA 510(k)

FDA Class 2 ·Microbiology

SMART-READ EZTEST-STEAM SCBI AND TEST PACK

FDA 510(k)

FDA Class 2 ·General Hospital

VISIONLINK INTERFILE CONVERSION SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

SPECIFIC IGE EIA-TURBO ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

BINAX LEGIONELLA URINARY ANTIGEN EIA

FDA 510(k)

FDA Class 2 ·Microbiology

VENTRESCREEN, HCG URINE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO FLUROTEX SURGICAL MESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MICRO TARGETING DRIVE SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

MICROTABLE SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology