MODIFIED DDI SEROCARD CMV IGG TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

COAT-A-COUNT(TM) FENTANYL (TKFN1)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Bio2 CLM BG Bioactive Scaffold

FDA 510(k)

FDA Class 2 ·Orthopedic

SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B

FDA 510(k)

FDA Class 2 ·Radiology

CEROX MODEL 3210

FDA 510(k)

FDA Class 2 ·Cardiovascular

ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE DISINFECTION UNITS, ODOROX(R) SLIMLINE/RX (TM) SLIMLI

FDA 510(k)

FDA Class 2 ·General Hospital

GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SPERM WASHING MEDIUM #9983 & MODIFIED #9984

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HTF MEDIUM AND MODIFIED HTF MEDIUM-HEPES

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SPINEWORKS ANTERIOR LUMBAR DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

DOUBLE ANTIBODY BENZODIAZPINES #KBZD1, KBZD5

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ENGSTROM ERICA II RESPIRATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

RESISTAL P

FDA 510(k)

FDA Class 2 ·Dental

ACE STAPLER AND CARTRIDGE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

FDA 510(k)

FDA Class 2 ·Microbiology

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