Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Meprobamate Test System

FDA classification

FDA Class 2 ·Meprobamate Test System

BK-A; BK-B; BK-IS SEALING CAP

FDA 510(k)

FDA Class 2 ·Cardiovascular

Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LBK 1244 DELFIA HCG KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Easi-Vue® embolic microspheres System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Easi-Vue embolic microspheres System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·DIASORIN ETI-AB-HAVK PLUS ASSAY

Changer, Tube, Endotracheal

FDA Pre-Market Approval

FDA Class 2 ·ENDOTRACHEAL TUBE CHANGERS

Alinity m BKV

FDA 510(k)

FDA Class 2 ·Microbiology

cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

FDA 510(k)

FDA Class 2 ·Microbiology

INTELEPACS, MODEL VERSION 3.X.X

FDA 510(k)

FDA Class 2 ·Radiology

NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474

FDA 510(k)

FDA Class 2 ·Anesthesiology

HAMILTON-T1

FDA 510(k)

FDA Class 2 ·Anesthesiology

VENTILATOR #1

FDA 510(k)

FDA Class 2 ·Anesthesiology

NEWPORT E500 WAVE VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

M1145 (UPS1-1.25K-1G-MP) UPS

FDA 510(k)

FDA Class 2 ·Anesthesiology

HEALTHDYNE IMPLUSE VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

Hamilton-G5

FDA 510(k)

FDA Class 2 ·Anesthesiology