CAMSYS 6300

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DACOMED CYSTOMETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LIFE-TECH #1857 PRESSURE/POLOT MODULE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AQUA-GEL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ADVANCE MODEL UDS-ADV

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VOLUME TRANSDUCER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter))

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cystometer, Electrical Recording

FDA classification

FDA Class 2 ·Cystometer, Electrical Recording

ELECTRO-IMMUNO-QUANTITATION (EIQ)

FDA 510(k)

FDA Class 2 ·Immunology

AI Platform 2.0 (AIP002)

FDA 510(k)

FDA Class 2 ·Radiology

Strain AI (SAI001)

FDA 510(k)

FDA Class 2 ·Radiology

MH1 MICROHOLTER RECORDER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLINCAL HAND MASTER SYSTEM MODEL # EXH9000-002

FDA 510(k)

FDA Class 2 ·Orthopedic

HEMOCLAV VENOUS CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Bladder AI (AIBV01)

FDA 510(k)

FDA Class 2 ·Radiology

AI Platform (AIP001)

FDA 510(k)

FDA Class 2 ·Radiology

Lung AI (LAI001)

FDA 510(k)

FDA Class 2 ·Radiology

Exo Iris

FDA 510(k)

FDA Class 2 ·Radiology

Exo Iris (El2001)

FDA 510(k)

FDA Class 2 ·Radiology

CLINICAL HANDMASTER SYSTEM OR CHMS

FDA 510(k)

FDA Class 2 ·Orthopedic