AQUADEX FLEXFLOW SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Aquadex FlexFlow System 2.0

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DRUGBOX

FDA 510(k)

FDA Class 2 ·General Hospital

INFUSION CATHETER EXTENSION SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

THERM O DRUG MODEL HT-747

FDA 510(k)

FDA Class 2 ·General Hospital

DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AQUADEX SYSTEM 100, MODEL A1100

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO AQUADEX FLEXFLOW SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MARK I HUMIDIFIER

FDA 510(k)

FDA Class 2 ·Anesthesiology

HOT SACK

FDA 510(k)

FDA Class 2 ·General Hospital

A-1 IN-HOME PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MINI-BEEP

FDA 510(k)

FDA Class 2 ·Physical Medicine

SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AQUADEX SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACU-SLIDE TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SYSTEM 100 ULTRAFILTRATION CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CEOS Sabouraud dextrose agar W/CAF 500mg

Device

EU IVDD · Eu Ivd General ·C-pharm d.o.o.·On the market

CMV IgG Test System, 120 Tests

FDA UDI

Bion Enterprises, Ltd.·B110CMG1200·