INION CPS ORBITAL PLATES

FDA 510(k)

FDA Class 2 ·Dental

CARDIOCAP(TM) CMO-104 MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

CRANEX D

FDA 510(k)

FDA Class 2 ·Dental

PB GRAPHICS PRINTER AND PB VIDEO DISPLAY

FDA 510(k)

FDA Class 2 ·Anesthesiology

eMotion Faros ECG Mobile

FDA 510(k)

FDA Class 2 ·Cardiovascular

Planmeca Viso

FDA 510(k)

FDA Class 2 ·Radiology

CARDIOCAP(TM) CMX-104 MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

PB VIDEO DISPLAY TO PB251 PULSE OXIMETER UPGRADE

FDA 510(k)

FDA Class 2 ·Cardiovascular

PM2002 CC AND PM2002 EC

FDA 510(k)

FDA Class 1 ·Dental

MRCAT brain

FDA 510(k)

FDA Class 2 ·Radiology

DENTOCULT CULTURE-PADDLE

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

1.5MM BONE FIXATION KIT

FDA 510(k)

FDA Class 2 ·Orthopedic

INION HEXALON BIODEGRADABLE ACL/PCL SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT

FDA 510(k)

FDA Class 2 ·Radiology

DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H

FDA 510(k)

FDA Class 2 ·Orthopedic

Contour+ (MVision AI Segmentation)

FDA 510(k)

FDA Class 2 ·Radiology

BIOSORBFX O/M 2.0/2/4 SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

PANORAMIC X-RAY UNITS, MODIFICATION

FDA 510(k)

FDA Class 2 ·Dental

ORTHOPANTOMOGRAPH OP300

FDA 510(k)

FDA Class 2 ·Dental