DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH

FDA 510(k)

FDA Class 2 ·Cardiovascular

INNOVANCE D-DIMER, MODEL OPBP09

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STRATUS CS ACUTE CARE D-DIMER

FDA 510(k)

FDA Class 2 ·Hematology

UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM)

FDA 510(k)

FDA Class 2 ·Orthopedic

ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)

FDA 510(k)

FDA Class 2 ·Orthopedic

MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Orthopedic

COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT

FDA 510(k)

FDA Class 2 ·Orthopedic

KENSEY NASH ECM SURGICAL PATCH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS FOLATE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCESS FOLATE ASSAY (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Access hs Tnl

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SYNCHRON SYSTEMS AMPHETAMINE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry