CLINI-CALC

FDA 510(k)

FDA Class 2 ·Anesthesiology

KING DIAGNOSTICS GLUCOSE (HK) REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 9300

FDA 510(k)

FDA Class 2 ·Cardiovascular

Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

WATER PURIFICATION COMPONENTS AND SYSTEMS HEMODIALYSIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GYNECOLOGIC EXAMINATION KIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647

FDA 510(k)

FDA Class 2 ·Immunology

KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 58L

FDA 510(k)

FDA Class 2 ·Cardiovascular

VARIANT BETA-THALASSEMIA SHORT PROGRAM

FDA 510(k)

FDA Class 2 ·Hematology

KIRSCHNER C-2 OSTEOCAP TOTAL HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

RINGLOC BI-POLAR ACETABULAR COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

C2000 AUTOMATED MANIFOLD KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAINBOND A

FDA 510(k)

FDA Class 2 ·Dental

INSITE STEERABLE GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA.

FDA 510(k)

FDA Class 2 ·Microbiology

SONOSITE EDGE ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BAG SPIKE EXTENSION SET

FDA 510(k)

FDA Class 2 ·General Hospital