EYESOPEN TONOMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Plexus

FDA 510(k)

FDA Class 2 ·Cardiovascular

IDECAP DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ASTar BC G- Kit and ASTar Instrument

FDA 510(k)

FDA Class 2 ·Microbiology

ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+

FDA 510(k)

FDA Class 2 ·Radiology

ScandiDos Delta4 Phantom+

FDA 510(k)

FDA Class 2 ·Radiology

Delta4 Insight

FDA 510(k)

FDA Class 2 ·Radiology

Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)

FDA 510(k)

FDA Class 2 ·Radiology

DiviTum TKa

FDA 510(k)

FDA Class 2 ·Immunology

LEGACY MEDICAL ECO-CHOICE DISPOSABLE BLOOD PRESSURE CUFF

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANA ANTISERA CONTROL KIT

FDA 510(k)

FDA Class 2 ·Immunology

MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST

FDA 510(k)

FDA Class 2 ·Immunology

RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

AC3 Series Intra-Aortic Balloon Pump (IABP)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACCESS R-CLONE ANA PROFILE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

RHEUMELISA ASSAY FOR SM AUTOANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

Wishbone HA

FDA 510(k)

FDA Class 2 ·Dental