eMotion Faros ECG Mobile

FDA 510(k)

FDA Class 2 ·Cardiovascular

Planmeca Viso

FDA 510(k)

FDA Class 2 ·Radiology

Bemer Therapy System Evo

FDA 510(k)

FDA Class 2 ·Physical Medicine

CARDIOCAP(TM) CMX-104 MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)

FDA 510(k)

FDA Class 2 ·Neurology

PB VIDEO DISPLAY TO PB251 PULSE OXIMETER UPGRADE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MRCAT brain

FDA 510(k)

FDA Class 2 ·Radiology

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

IPS e.max® Press Abutment Solutions for Viteo Base Ti

FDA 510(k)

FDA Class 2 ·Dental

ORTHOPANTOMOGRAPH OP300

FDA 510(k)

FDA Class 2 ·Dental

FS Ergo

FDA 510(k)

FDA Class 2 ·Dental

CARESCAPE MONITOR B650

FDA 510(k)

FDA Class 2 ·Cardiovascular

PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology