Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i

FDA 510(k)

FDA Class 2 ·Radiology

E100A PULSE OXIMETER FINGER SENSOR/PROBE

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPO2 WRAP SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPO2 WRAP SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLEXI-SITE SP02 EAR SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLEXI-SITE (E203-01)/ FLEXI-FIT (E300)

FDA 510(k)

FDA Class 2 ·Cardiovascular

EPIC SPO2 FINGER SENSOR, MODEL E412-20

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

E100 SERIES SPO2 SENSORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

STAT-SHELL DISPOSABLE SP02 SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

OXIMETER PRE-AMP CABLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLEXI-LUME LED SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

FLEXI-SITE SP02 EAR SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09

FDA 510(k)

FDA Class 2 ·Cardiovascular

STAT-SHELL DISPOSABLE SPO2 SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Neodent Instruments Kits

FDA 510(k)

FDA Class 2 ·General Hospital

Neodent Implant System - GM Line

FDA 510(k)

FDA Class 2 ·Dental

Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants

FDA 510(k)

FDA Class 2 ·Dental