MRI Planner

FDA 510(k)

FDA Class 2 ·Radiology

DEPUY CAS HEMI ASR HIP INSTRUMENTS

FDA 510(k)

FDA Class 2 ·Neurology

NEVONI CLASSIC, MODEL 6600-PO

FDA 510(k)

FDA Class 2 ·Anesthesiology

TAHOE SURGICAL INSTRUMENTS LIGATURE DEVICE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TSI WILLEN-REICH NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Access hs Tnl

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES

FDA 510(k)

FDA Class 2 ·Anesthesiology

iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OTOFLEX 100 TYE 1012

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BIOLIGHT BIODYNAM

FDA 510(k)

FDA Class 2 ·Physical Medicine

AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CRESCO TI IMPLANT CONCEPT

FDA 510(k)

FDA Class 2 ·Dental

SPEECHLINK 100 TYPE 1053

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)

FDA 510(k)

FDA Class 2 ·Dental

AI100 with Shonit

FDA 510(k)

FDA Class 2 ·Hematology

Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK

FDA 510(k)

FDA Class 2 ·Cardiovascular

Wireless Smart Gluco-Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Tisuthes e-PTFE Surgical Patch

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology