ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72

FDA 510(k)

FDA Class 2 ·Hematology

ACSYS SHEARER ACETABULAR CUP PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SIEMENS SIRECUST 732, PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

LABELING CHANGE COAT-A-COUNT COCAINE METABOLITE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HALL VEIN STRIPPER

FDA 510(k)

FDA Class 2 ·Cardiovascular

R&D BATTERIES PART NOS. 5041 & 5655

FDA 510(k)

FDA Class 2 ·General Hospital

THE DDI SERODOT RUBELLA IGG TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

MODEL T11 FLUIDOTHERAPY UNIT

FDA 510(k)

FDA Class 2 ·Physical Medicine

LABELING CHANGE COAT-A-COUNT MORPHINE IN URINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Z-800 INFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

R&D BATTERIES PART NOS. 5015, 5016, 5037 AND 5051

FDA 510(k)

FDA Class 2 ·General Hospital

THE IMAGE/R

FDA 510(k)

FDA Class 2 ·Radiology

PRECEPT CEFTIZOXIME

FDA 510(k)

FDA Class 2 ·Microbiology

Lung-CAD

FDA 510(k)

FDA Class 2 ·Radiology

R AND D BATTERIES, INC. PART NOS. 5038 & 5347

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MODIFIED DDI SEROCARD HERPES IGG TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

MILENIA(TM) OPIATES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ULTRAPAC II SX PLUS (TM)

FDA 510(k)

FDA Class 2 ·Neurology