VAC FIX(R) SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

N-A-G TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ORAL SLEEP DISORDER AID

FDA 510(k)

FDA Class 2 ·Dental

N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

UNI-KNEE 2.0

FDA 510(k)

FDA Class 2 ·Neurology

Pasteur Pipette 3mL, Pasteur Pipette 1mL

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED

FDA 510(k)

FDA Class 2 ·Neurology

MRI Planner

FDA 510(k)

FDA Class 2 ·Radiology

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

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

A’TOMIC™ Nitinol Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

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

BioHealx Anal Fistula Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

QLICKSMART

FDA 510(k)

FDA Class 2 ·General Hospital

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