UNOMEDICAL MONICA INFUSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

SIGMA 7000 AND SIGMA70002

FDA 510(k)

FDA Class 2 ·General Hospital

SIGMA 8000 AND SIGMA 8002

FDA 510(k)

FDA Class 2 ·General Hospital

SIGMA 8000 AND SIGMA 8002

FDA 510(k)

FDA Class 2 ·General Hospital

INNOFLUOR GENTAMICIN ASSAY SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INNOFLUOR THEOPHYLLINE ASSAY SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INNOFLUOR AMIKACIN ASSAY SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INNOFLOUR TOPIRAMATE REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INNOFLOUR CALIBRATOR REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INNOFLUOR QUINIDINE ASSAY SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INNOFLUOR PHENOBARBITAL ASSAY SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INNOFLUOR PHENYTOIN ASSAY SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INNOFLUOR GENTAMICIN ASSAY SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BBP BONE SUBSTITUTES

FDA 510(k)

FDA Class 2 ·Dental

HAND DRILL, MODEL 11-9901-7

FDA 510(k)

FDA Class 2 ·Neurology

ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)

FDA 510(k)

FDA Class 2 ·Immunology

SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901

FDA 510(k)

FDA Class 2 ·Neurology

ARIOL HER-2/NEU IHC

FDA 510(k)

FDA Class 2 ·Hematology

SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL

FDA 510(k)

FDA Class 2 ·Neurology

Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set

FDA 510(k)

FDA Class 2 ·General Hospital