PATHFAST®hs-cTnI-II

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARISTON PHC

FDA 510(k)

FDA Class 2 ·Dental

ARISTON PHC LINER

FDA 510(k)

FDA Class 2 ·Dental

PERSONAL HEALTH CENTER (PHC)

FDA 510(k)

FDA Class 2 ·Cardiovascular

PROTON PHC 8731 10 SECOND DIGITAL THERMOMETER; PROTON PHC 109 EAR THERMOMETER; PROTON 889 EAR THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-3)

FDA 510(k)

FDA Class 2 ·Physical Medicine

PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-2)

FDA 510(k)

FDA Class 2 ·Physical Medicine

LifeShield Infusion Safety Software Suite

FDA 510(k)

FDA Class 2 ·General Hospital

Dose IQ Safety Software

FDA 510(k)

FDA Class 2 ·General Hospital

Vigilant Software Suite – Vigilant Master Med

FDA 510(k)

FDA Class 2 ·General Hospital

BD Intelliport System

FDA 510(k)

FDA Class 2 ·General Hospital

BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231)

FDA 510(k)

FDA Class 2 ·General Hospital

BECTON DICKINSON INTELLIPORT SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0

FDA 510(k)

FDA Class 2 ·General Hospital

Dose IQ Safety Software

FDA 510(k)

FDA Class 2 ·General Hospital

LifeShield™ Infusion Safety Software Suite

FDA 510(k)

FDA Class 2 ·General Hospital

Infusion Safety Management Software

FDA classification

FDA Class 2 ·Infusion Safety Management Software

AHCS HEMOPERFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OXYPULSE EOC I, EOC II & EOC R

FDA 510(k)

FDA Class 2 ·Anesthesiology

SOUNDSKIN PHOTOTHERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery