SPECIFIC IGE EIA-ULTRA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

DEMAND ETHYL ALCOHOL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN

FDA 510(k)

FDA Class 2 ·Immunology

RELIEFBAND DEVICE, MODELS RB-DL, RB-EL, RB-RL

FDA 510(k)

FDA Class 2 ·Neurology

REFRACTIVE SURGERY BLADES

FDA 510(k)

FDA Class 1 ·Ophthalmic

SUTTER CPM 2000

FDA 510(k)

FDA Class 1 ·Physical Medicine

PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.

FDA 510(k)

FDA Class 2 ·Dental

VASCULAR ACCESS PORT/CATH CAT.#VP-XXXX VASPORT SER

FDA 510(k)

FDA Class 2 ·Cardiovascular

POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE (BLACK)

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

VENTREX ALLERGEN DISC

FDA 510(k)

FDA Class 2 ·Immunology

FIA Blood Glucose Monitoring System (G2)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY

FDA 510(k)

FDA Class 2 ·Immunology

NMI SOFTWARE

FDA 510(k)

FDA Class 2 ·Neurology

KOVA LIQUA-TROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 250mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 500mL bottle

FDA 510(k)

FDA Unclassified ·Unknown

CAP-35 AND CAP35 F

FDA 510(k)

FDA Class 2 ·Cardiovascular

GLUCOLEADER VALUE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PROSPECT CRYPTOSPORIDIUM RAPID ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology