System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·FLOW MIC SYSTEM

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·3M BRAND MICROBIAL PROFILE SYSTEM

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·MAGNISCAN 5000 MRI SYSTEM

RETINA TOMOGRAPH AND FLOWMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

RETINA FLOWMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

RETINA ANGIOGRAPH

FDA 510(k)

FDA Class 2 ·Ophthalmic

Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

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