DENU Composite Resin, DENU Flow Resin

FDA 510(k)

FDA Class 2 ·Dental

DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)

FDA 510(k)

FDA Class 2 ·Dental

System, Imaging, Pulsed Doppler, Ultrasonic

FDA Pre-Market Approval

FDA Class 2 ·HDI 3000 ULTRASOUND SYSTEM

DIGITAL DENTAL INTRA ORAL SENSOR; HDI 1000, HDI 1000A

FDA 510(k)

FDA Class 2 ·Radiology

DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A

FDA 510(k)

FDA Class 2 ·Radiology

LEVEL 10 HDI

FDA 510(k)

FDA Class 2 ·Radiology

System, Imaging, Pulsed Doppler, Ultrasonic

FDA Pre-Market Approval

FDA Class 2 ·ULTRAMARK 9 HIGH DEFINITION IMAGING UULTRASOUND SYSTEM

System, Imaging, Pulsed Doppler, Ultrasonic

FDA Pre-Market Approval

FDA Class 2 ·HDI 3000 ULTRASOUND SYSTEM WITH L12-5 SCANHEAD

Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S

FDA 510(k)

FDA Class 2 ·Dental

HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

X Sensor (Model: IOS-A15IF, HDI-15DGF)

FDA 510(k)

FDA Class 2 ·Dental

ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ATAD ARD CATHETER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DILATOR, MIZUTANI LAMINARIA TENT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LAMINARIA

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LAMINARIA JAPONICA CERVICAL DILATOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology