SELITHERM, MODEL C100

FDA 510(k)

FDA Class 2 ·Physical Medicine

PEEP VALVE

FDA 510(k)

FDA Class 2 ·Anesthesiology

MAXVIEW DIAGNOSTIC WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

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

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FEATHERLITE DIODE LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LATERAL FLARE INTERNAL COLLAR (LFIC)

FDA 510(k)

FDA Class 2 ·Orthopedic

DIOSCAN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

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

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

TONOPORT VI

FDA 510(k)

FDA Class 2 ·Cardiovascular

BioHealx Anal Fistula Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery