Low Ejection Fraction AI-ECG Algorithm

FDA 510(k)

FDA Class 2 ·Cardiovascular

Eko Low Ejection Fraction Tool (ELEFT)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Reduced Ejection Fraction Machine Learning-Based Notification Software

FDA classification

FDA Class 2 ·Reduced Ejection Fraction Machine Learning-Based Notification Software

PRECISION MED PRODUCTS LTD HYPERINFLATION SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

PRECISION MED PRODUCTS LTD GUEDEL AIRWAYS

FDA 510(k)

FDA Class 2 ·Anesthesiology

PERLINK CASSETTE, KIRAN CASSETTE

FDA 510(k)

FDA Class 2 ·Radiology

MERETE LOCKING BONE PLATE SYSTEM II

FDA 510(k)

FDA Class 2 ·Orthopedic

THERMOMETER, MERCURY/CLINICAL

FDA 510(k)

FDA Class 2 ·General Hospital

MERETE BLP SMALL FRAGMENT LOCKING BONE PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

MERETE LOCKING BONE PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MERETE 3.0 AND 3.5 MM LOCKING SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

MilkMate Breast Pump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MERETE LOCKING BONE PLATE SYSTEM III

FDA 510(k)

FDA Class 2 ·Orthopedic

MERETE COMPRESSION SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

ME-APDS™; MAGENTIQ-COLO™

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AHI System

FDA 510(k)

FDA Class 2 ·Cardiovascular

HOUSE INFRARED/VIDEO ELECTRONYSTAGMOGRAPH SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

AHI System

FDA 510(k)

FDA Class 2 ·Cardiovascular

EYESOPEN TONOMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic