EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP; TRUCOUNT ABSOLUTE COUNT TUBES

FDA 510(k)

FDA Class 2 ·Hematology

12-LEAD GLOVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIAC COMPUTATION SOFTWARE PACKAGE

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES

FDA 510(k)

FDA Class 2 ·Hematology

VOLUME COMPUTATION SOFTWARE PACKAGE

FDA 510(k)

FDA Class 2 ·Cardiovascular

3.7MM/5.0MM DYNAMIC LOCKING SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

TAS-211/2.3 ULTRATHIN FLEXIBLE ENDOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ULTRATHIN FLEXIBLE ENDOSCOPE TAS-211/2.3

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

WATCH-PAT200U (WP200U)

FDA 510(k)

FDA Class 2 ·Anesthesiology

TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES

FDA 510(k)

FDA Class 2 ·Hematology

ASPARTATE AMINOTRANSFERASE (AST) TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TOTAL PROTEIN TEST (TPRO)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LACTATE DEHYDROGENASE (LD)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EMDS ALBUMIN (ALB) TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EMDS ALKANINE PHOSPHATASE (ALP) TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HAIRMAX DUAL 12

FDA 510(k)

FDA Class 2 ·Physical Medicine