High Performance Liquid Chromatography For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·BIO-RAD CYCLOSPORINE BY HPLC TEST

LMNT O2

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ERYTHROCYTE TEST

FDA 510(k)

FDA Class 2 ·Hematology

COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE

FDA 510(k)

FDA Class 2 ·Hematology

MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM

FDA 510(k)

FDA Class 2 ·Immunology

MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT, BIO-CUT - SOFT TISSUE BIOPSY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

QCT-BONE MINERAL PHANTOM

FDA 510(k)

FDA Class 2 ·Radiology

VEOS Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MOD

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SaliPen

FDA 510(k)

FDA Class 2 ·Dental

GenNarino

FDA 510(k)

FDA Class 2 ·Dental

C-THV SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ACS MODEL NCP-2

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE)

FDA 510(k)

FDA Class 2 ·General Hospital

MEDIZIV INFUSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

Infrascanner Model 2500 (Model 2500)

FDA 510(k)

FDA Class 2 ·Ophthalmic

FRESENIUS HAEMODIALYSIS A2008

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

THE IC-PRO SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CIV-OB (PLUS)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology