syngo Ultrasound Apps Suite (sUSAS)

FDA 510(k)

FDA Class 2 ·Radiology

e-SDF

FDA 510(k)

FDA Class 2 ·Dental

Samsung ECG App v 1.3 (ECG)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Informed Vital Core Application (IVC App)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACCU-CHEK Connect Diabetes Management App

FDA 510(k)

FDA Class 2 ·Anesthesiology

ACCU-CHEK CONNECT DIABETES MANAGEMENT APP

FDA 510(k)

FDA Class 2 ·Anesthesiology

MDHearingAid app, MDHearingAid Smart hearing aids

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CO Check Pro, CO Screen

FDA 510(k)

FDA Class 2 ·Anesthesiology

SafeBreath Filter Mouthpiece

FDA 510(k)

FDA Class 2 ·Anesthesiology

Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Caretaker Remote Display App and Caretaker Software Library

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP.

FDA 510(k)

FDA Class 2 ·Cardiovascular

DISPOSABLE HEATING TUBING SET #7642HSES

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MULTI HI-FLO PNEU, WISAP #7080

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

POWER-DRIVE, WISAP MODEL #7688PD/7688PD1

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FLOW-THERME, WISAP #7642

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HI-FLO THERME PNEU 45, WISAP #7083, 7083V

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

WAVETRONIC 5000 DIGITAL HF SURGICAL UNIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery