Caption Interpretation Automated Ejection Fraction Software

FDA 510(k)

FDA Class 2 ·Radiology

Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan

FDA classification

FDA Class 2 ·Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan

EKOS ultrasound EVD Device, EVD Control Unit

FDA 510(k)

FDA Class 2 ·Neurology

IVD TECHNOLOGIES ACHRAB TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set

FDA 510(k)

FDA Class 2 ·Neurology

SureFlo EVD Catheter

FDA 510(k)

FDA Class 2 ·Neurology

CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET

FDA 510(k)

FDA Class 2 ·Neurology

AVD INTIMAX CHOLANGIOGRAPHY CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AVD RIGHT RADIAL DRAPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AVD INTIMAX OCCLUSION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CVD BULLET INFUSION CATYHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

AVD INTIMAX THROMBECTOMY CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96

FDA 510(k)

FDA Class 2 ·Microbiology

GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF

FDA 510(k)

FDA Class 2 ·Microbiology

IVD CRYPTO/GIARDIA DFA

FDA 510(k)

FDA Class 2 ·Microbiology

IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96

FDA 510(k)

FDA Class 2 ·Microbiology

AVD INTIMAX (TM) BILIARY CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FLASH EVD System (10-0002)

FDA 510(k)

FDA Class 2 ·Neurology

CODMAN BACTISEAL EVD CATHETER SET

FDA 510(k)

FDA Class 2 ·Neurology

CVD BULLETT PERIPHERAL INFUSION CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital