T3 Platform Software

FDA 510(k)

FDA Class 2 ·Cardiovascular

MicroScan Prompt Inoculation System-D

FDA 510(k)

FDA Class 2 ·Microbiology

GAST STAT MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Transvaginal Access Platform

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CELL-DYN 1000 AUTOMATED HEMATOLOGY ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring

FDA 510(k)

FDA Class 2 ·Dental

010 HI-TOR INTER/STAND GUIDWIRE PRESHAPE TIP/MODIF

FDA 510(k)

FDA Class 2 ·Cardiovascular

COLGATE ODONTOSON ULTRASONIC SCALER

FDA 510(k)

FDA Class 2 ·Dental

EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

IVAC SYRINGE PUMP - 740 SERIES

FDA 510(k)

FDA Class 2 ·General Hospital

BI-N

FDA 510(k)

FDA Class 2 ·Radiology

SOFIA EX Intracranial Support Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EndeavorRx

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

embecta Insulin Delivery System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SBDX MOBILE FLUOROSCOPY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

EASYSTAT SODIUM/POTASSIUM ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FIRARD II/ TDP LAMP

FDA 510(k)

FDA Class 2 ·Physical Medicine

SPIRIT RIDGE SILICONE CARVING BLOCK

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SURGICAL STAPLE MARKER DEVICE (MODIFY)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery