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

MATRYX INTERFERENCE SCREW, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5

FDA 510(k)

FDA Class 2 ·Orthopedic

TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)

FDA 510(k)

FDA Class 2 ·Neurology

INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES, MODELS PLT-1058 AND PLT-1059

FDA 510(k)

FDA Class 2 ·Dental

PLANMED SOPHIE

FDA 510(k)

FDA Class 2 ·Radiology

MAMMOGRAPH MAMMOGRAPHIC X-RAY DEVICE

FDA 510(k)

FDA Class 2 ·Radiology

MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA

FDA 510(k)

FDA Class 2 ·Microbiology

CARESCAPE MONITOR B450

FDA 510(k)

FDA Class 2 ·Cardiovascular

INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001

FDA 510(k)

FDA Class 2 ·Orthopedic

PLANMECA INTRACAM STATION

FDA 510(k)

FDA Class 1 ·Dental