TrueBalance™ Surgical System

FDA 510(k)

FDA Class 2 ·Neurology

TDX(R)/TDXFLX(R) FREE PHENYTOIN II

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ONLINE TDM Phenytoin - Free Phenytoin application

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)

FDA classification

FDA Class 2 ·Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)

Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y

FDA 510(k)

FDA Class 2 ·General Hospital

Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107

FDA 510(k)

FDA Class 2 ·General Hospital

Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G

FDA 510(k)

FDA Class 2 ·Cardiovascular

Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E

FDA 510(k)

FDA Class 2 ·General Hospital

Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)

FDA 510(k)

FDA Class 2 ·General Hospital

Water Container (MAJ-901); Water Container (MAJ-902)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COULTER CLONE MO2

FDA 510(k)

FDA Class 2 ·Hematology

Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B

FDA 510(k)

FDA Class 2 ·Cardiovascular

Luer-Split MAJ-2092

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LTF-Y0009; MAJ-YOO41; XOEV-3D1

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD)

FDA 510(k)

FDA Class 2 ·General Hospital

SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL SV-S23BL35VS

FDA 510(k)

FDA Class 2 ·General Hospital