MSC SFM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Mobility Scooter (MS160A)

FDA 510(k)

FDA Class 2 ·Physical Medicine

U-Blade Veress Needle

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

U-IGNITE Bladeless Trocar

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Balloon Inflation System

FDA 510(k)

FDA Class 2 ·Orthopedic

KAY-PLUS & VARIOUS VANIA SANITARY LINERS & PADS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Yushan X-Ray Flat Panel Detector with DROC

FDA 510(k)

FDA Class 2 ·Radiology

Portable Oxygen Concentrator (P2-TOC)

FDA 510(k)

FDA Class 2 ·Anesthesiology

Afinion HbA1c Dx on Afinion 2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer

FDA 510(k)

FDA Class 2 ·Hematology

Afinion HbA1c Dx

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Alere Afinion HbA1c, Alere Afinion AS100 Analyzer

FDA 510(k)

FDA Class 2 ·Hematology

THD BANDY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WINSIX Implant System

FDA 510(k)

FDA Class 2 ·Dental

YOUNG AGAIN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

VESALIUS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

THD N-ANO ANOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cyber Blade

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology