Athena GTX Device Management Suite (ADMS) Software

FDA 510(k)

FDA Class 2 ·Cardiovascular

WVSM (Wireless Vital Signs Monitor) RWC + miniCap

FDA 510(k)

FDA Class 2 ·Cardiovascular

TACVAC

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MINI-MEDIC

FDA 510(k)

FDA Class 2 ·Cardiovascular

WiCap

FDA 510(k)

FDA Class 2 ·Cardiovascular

PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)

FDA 510(k)

FDA Class 2 ·Physical Medicine

WVSM (WIRLESS VITAL SIGNS MONITOR)

FDA 510(k)

FDA Class 2 ·Cardiovascular

WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLYDE CORONARY GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

AIRCAST VENAFLOW ELITE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

OC-Light S FIT

FDA 510(k)

FDA Class 2 ·Hematology

HANNIBAL GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

BRAINLAB CT/X-RAY LOCALIZER

FDA 510(k)

FDA Class 2 ·Radiology

WVSM Pro (Series) (500-0030-XX)

FDA 510(k)

FDA Class 2 ·Cardiovascular

A Breathing System (ABS)

FDA 510(k)

FDA Class 2 ·Neurology

NG-Test® CTX-M MULTI

FDA 510(k)

FDA Class 2 ·Microbiology

ANEROID AND MERCURIAL SPHYGMOMANOMETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK

FDA 510(k)

FDA Class 2 ·Dental

ASTRA DISPOSABLE SPRAY CANNULA

FDA 510(k)

FDA Class 2 ·Anesthesiology

ASTRA LIGHTWEIGHT STAINLESS STEEL SELF ASPIR/SYRIN

FDA 510(k)

FDA Class 2 ·Dental