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

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

CARDIOCAP(TM) CM-104 MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MVision AI Segmentation

FDA 510(k)

FDA Class 2 ·Radiology

CARDIOCAP II TM CH-RESP MONITORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

INION CPS BABY 1.5 BIOABSORBABLE SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

OP300

FDA 510(k)

FDA Class 2 ·Radiology

PYLORISET

FDA 510(k)

FDA Class 1 ·Microbiology

AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX

FDA 510(k)

FDA Class 2 ·Anesthesiology