THYROSAMPLER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)

FDA 510(k)

FDA Class 2 ·Cardiovascular

POLY-LITE MODEL 1000

FDA 510(k)

FDA Class 2 ·Dental

Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System

FDA 510(k)

FDA Class 2 ·Cardiovascular

MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated

FDA 510(k)

FDA Class 2 ·Cardiovascular

IL TEST CALCIUM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PRODOSE AAD SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

HALOLITE AAD SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

EMIT-AAD THEOPHYLLINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EMIT AAD THEOPHYLLINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

I-NEB AAD SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

I-NEB INSIGHT AAD SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

IL TEST DIGOXIN, PN 181761-00

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

IL TEST FIBRINOGEN-C

FDA 510(k)

FDA Class 2 ·Hematology

MOTION TRACKING

FDA 510(k)

FDA Class 2 ·Radiology

IL TEST(TM) PROTEIN S

FDA 510(k)

FDA Class 2 ·Hematology

IL TEST(TM) PRO-CHROM

FDA 510(k)

FDA Class 2 ·Hematology

IL TEST BETA-2MICROGLOBULIN

FDA 510(k)

FDA Class 2 ·Immunology

IL TEST PHENOBARBITAL CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology