DPL THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

ELECTRO SENSOR -BODY COMPOSITION

FDA 510(k)

FDA Class 2 ·Cardiovascular

ValvuloPro Valvuloplasty Balloon Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MultiStage Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RelieforMe TENS/EMS Device Model UPK-GE01

FDA 510(k)

FDA Class 2 ·Physical Medicine

ValvuloPro Valvuloplasty Balloon Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ArtPix Mobile EZ2GO

FDA 510(k)

FDA Class 2 ·Radiology

Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Dewin Blastocyst Medium (with HSA and without HSA)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Multistage Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·ACHILLES INSIGHT ULTRASONOMETER

ETCO2 Sensor

FDA 510(k)

FDA Class 2 ·Anesthesiology

Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+

FDA 510(k)

FDA Class 2 ·Anesthesiology

Disposable Sterile Syringe, Disposable Sterile Syringe with Needle

FDA 510(k)

FDA Class 2 ·General Hospital

Reusable NIBP Cuff

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Temperature Probe

FDA 510(k)

FDA Class 2 ·General Hospital

TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026)

FDA 510(k)

FDA Class 2 ·Neurology