GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GentleCath Glide Intermittent Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER D, DM, AND OEM-D (SOFTWARE VERSION 5.1)

PROBE SHEATH FOR ADMS ULTRASOUND PROBE

FDA 510(k)

FDA Class 2 ·Radiology

BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE

FDA 510(k)

FDA Class 2 ·Hematology

Athena GTX Device Management Suite (ADMS) Software

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

PHASE II GBM IGG ANTIBODY EIA TEST

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE GBM ELISA

FDA 510(k)

FDA Class 2 ·Immunology

BIOPLEX VASCULITIS KIT

FDA 510(k)

FDA Class 2 ·Immunology

AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA

FDA 510(k)

FDA Class 2 ·Immunology

ATHENA MULTI-LYTE GBM TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

FLASH AR PENTA / FLASH AR PENTA QUICK

FDA 510(k)

FDA Class 2 ·Dental

CORPAK ENTERAL SOL ADM PUMP SET W/ SCREW

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PROBE SHEATH FOR ADMS & CAPISTRANO LABS TRANSREC.

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODEL 72-81-0 UNVENTED SOLUTION ADM. SET

FDA 510(k)

FDA Class 2 ·General Hospital

DURHAM; ADM. SET-LUER LOCK W/.22 MICRON FILTER

FDA 510(k)

FDA Class 2 ·General Hospital