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

BRAINLAB CT/X-RAY LOCALIZER

FDA 510(k)

FDA Class 2 ·Radiology

CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOPULMONARY BYPASS PUMP TUBING

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

FDA 510(k)

FDA Class 2 ·Cardiovascular

VACUUM-ASSISTED BLOOD COLLECTION SYSTEM

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

AIRO Computed Tomography (CT) X-ray System

FDA 510(k)

FDA Class 2 ·Radiology

AIRO Computed Tomography (CT) X-ray System

FDA 510(k)

FDA Class 2 ·Radiology

Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

FDA 510(k)

FDA Class 2 ·Dental

TOSHIBA TCT-600 COMPUTED TOMOGRAPHY (CT) X-RAY

FDA 510(k)

FDA Class 2 ·Radiology

NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TOSHIBA TCT-900S COMPUTED TOMOGRAPHY CT X-RAY SYS

FDA 510(k)

FDA Class 2 ·Radiology