Atellica® IM High-Sensitivity Troponin I (TnIH)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC

FDA 510(k)

FDA Class 2 ·Immunology

Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

GentleCath Glide Intermittent Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VCS S3Y

FDA 510(k)

FDA Class 2 ·Physical Medicine

VCS S3T

FDA 510(k)

FDA Class 2 ·Physical Medicine

VCS, MODEL S4T

FDA 510(k)

FDA Class 2 ·Physical Medicine

Disposable Brain Biopsy Needle 2.0

FDA 510(k)

FDA Class 2 ·Neurology

Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6

FDA 510(k)

FDA Class 2 ·Anesthesiology

PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA: CSF

FDA 510(k)

FDA Class 2 ·Anesthesiology

SPROTTE NRFit, Quincke NRFit

FDA 510(k)

FDA Class 2 ·Anesthesiology

Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7

FDA 510(k)

FDA Class 2 ·Anesthesiology

Emit® II Plus Buprenorphine Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GPC Intraheal Intramedullary Nailing System

FDA 510(k)

FDA Class 2 ·Orthopedic