SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971

FDA 510(k)

FDA Class 2 ·Hematology

SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MONOCLONAL ANTIBODY ANTI-CD2

FDA 510(k)

FDA Class 2 ·Hematology

SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE

FDA 510(k)

FDA Class 2 ·Anesthesiology

MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT

FDA 510(k)

FDA Class 2 ·Cardiovascular

2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES

FDA 510(k)

FDA Class 2 ·Orthopedic

EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE

FDA 510(k)

FDA Class 2 ·Cardiovascular

2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP; TRUCOUNT ABSOLUTE COUNT TUBES

FDA 510(k)

FDA Class 2 ·Hematology

MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS

FDA 510(k)

FDA Class 2 ·Radiology

MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

12-LEAD GLOVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIAC COMPUTATION SOFTWARE PACKAGE

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

RACEGEL

FDA 510(k)

FDA Unclassified ·Unknown