GEM HEART ONE/ONE+

FDA 510(k)

FDA Class 2 ·Cardiovascular

.9% NORMAL SALINE TUBE/STERILE WATER TUBE

FDA 510(k)

FDA Class 2 ·General Hospital

GAM-200

FDA 510(k)

FDA Class 2 ·Dental

STERIMED STERIZATION WRAPPER (NON-STERILE)

FDA 510(k)

FDA Class 2 ·General Hospital

GC GAM-100

FDA 510(k)

FDA Class 2 ·Dental

QUANTA LITE GBM ELISA

FDA 510(k)

FDA Class 2 ·Immunology

ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO

FDA 510(k)

FDA Class 2 ·Immunology

Advocate Insulin Pen Needles

FDA 510(k)

FDA Class 2 ·General Hospital

CAREMIBRAIN

FDA 510(k)

FDA Class 2 ·Radiology

WIELISA ANTI-GBM TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-GBM ANTIBODIES QUANTITATIVE KIT

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT

FDA 510(k)

FDA Class 2 ·Immunology

UMBILICAL CLAMP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MOUTH TO MOUTH BREATHER

FDA 510(k)

FDA Class 2 ·Anesthesiology

DISPOSABLE EMERGENCY OBSTETRICAL KIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

A1 ACOUSTIC RHINOMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

ATHENA MULTI-LYTE GBM TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)

FDA 510(k)

FDA Class 2 ·General Hospital

PHASE II GBM IGG ANTIBODY EIA TEST

FDA 510(k)

FDA Class 2 ·Immunology

WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology