Filter, Intravascular, Cardiovascular

FDA Pre-Market Approval

FDA Class 2 ·COOK BIRD'S NEST VENA CAVA FILTER

Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E

FDA 510(k)

FDA Class 2 ·General Hospital

Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107

FDA 510(k)

FDA Class 2 ·General Hospital

SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator

FDA 510(k)

FDA Class 2 ·Anesthesiology

Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)

FDA 510(k)

FDA Class 2 ·General Hospital

GaiaBone Bioabsorbable Bone Graft

FDA 510(k)

FDA Class 2 ·Orthopedic

Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G

FDA 510(k)

FDA Class 2 ·Cardiovascular

Axial3D Cloud Segmentation Service

FDA 510(k)

FDA Class 2 ·Radiology

Cumulus Functional Neurophysiology Platform

FDA 510(k)

FDA Class 2 ·Neurology

CARDIOBEEPER CB12/12, MODEL CB12/12

FDA 510(k)

FDA Class 2 ·Cardiovascular

BRIDGE III RECEIVER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Axial3D Cloud Segmentation Service

FDA 510(k)

FDA Class 2 ·Radiology

TELEPRESS III BLOOD PRESSURE MONITOR, MODEL TPIII

FDA 510(k)

FDA Class 2 ·Cardiovascular

Axial3D Insight

FDA 510(k)

FDA Class 2 ·Radiology

Aingeal Activity System

FDA 510(k)

FDA Class 2 ·Cardiovascular

HeartKey® Rhythm

FDA 510(k)

FDA Class 2 ·Cardiovascular

Axial3D Insight

FDA 510(k)

FDA Class 2 ·Radiology

zensor system

FDA 510(k)

FDA Class 2 ·Cardiovascular

B-Secur HeartKey Software Library

FDA 510(k)

FDA Class 2 ·Cardiovascular

CSM Submerged3-L Implant System

FDA 510(k)

FDA Class 2 ·Dental