Coalition AGX Plate and Coalition AGX Spacer

FDA 510(k)

FDA Class 2 ·Orthopedic

BIOLUCENT MAMMOGRAPHY CUSHION

FDA 510(k)

FDA Class 2 ·Radiology

Quick-20m

FDA 510(k)

FDA Class 2 ·Neurology

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

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

ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

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

FDA 510(k)

FDA Class 2 ·Cardiovascular

COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS

FDA 510(k)

FDA Class 2 ·Orthopedic

PowerDot PD-01MT2 Muscle Stimulator

FDA 510(k)

FDA Class 2 ·Physical Medicine

PowerDot PD-01MT2 Muscle Stimulator

FDA 510(k)

FDA Class 2 ·Physical Medicine

PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application)

FDA 510(k)

FDA Class 2 ·Physical Medicine

PowerDot PD-01M

FDA 510(k)

FDA Class 2 ·Physical Medicine

PowerDot PD-01MT

FDA 510(k)

FDA Class 2 ·Physical Medicine

Atellica® CH Creatinine_3 (Crea3)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CREATININE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry