MAC-LAB CARDIAC CATHETERIZATION LABORATORY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

ACE STAPLER AND CARTRIDGE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PROGEL (TM) DUAL ELECTRODE PAD, MODEL 8535

FDA 510(k)

FDA Class 2 ·Neurology

BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RNP ANTIBODY TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM

FDA 510(k)

FDA Class 2 ·Radiology

FREEZING MEDIUM (TEST YOLK BUFFER W/GLYCEROL)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ACKRAD H/S PROCEDURE TRAY

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NEER II TOTAL SHOULDER SYSTEM & PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

THE DDI SERODOT HERPES IGG TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

TDP INFRARED HEAT LAMP

FDA 510(k)

FDA Class 2 ·Physical Medicine

LABELING CHANGE COAT-A-COUNT METHAQUALONE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MED-FIBERS SURGICAL LASER FIBER, MED-FIBERS ENDO-ENT LASER PROBES, MED-FIBERS END- AND ASPIRATING LASER PROBES, MED-FIBE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

FDA 510(k)

FDA Class 2 ·Microbiology

ACKRAD PEDIATRIC C.P.A.P. SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

MODIFIED INFANT NASAL CANNULAE ASSEMBLY

FDA 510(k)

FDA Class 2 ·Anesthesiology