DENTATUS MTI MODULAR TRANSITIONAL IMPLANTS AND PROSTHETIC SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

INJECTION CAPS

FDA 510(k)

FDA Class 2 ·General Hospital

CLEARFIL PHOTO CORE PLT

FDA 510(k)

FDA Class 2 ·Dental

GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CLEARFIL MAJESTY FLOW

FDA 510(k)

FDA Class 2 ·Dental

MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CT-132

FDA 510(k)

FDA Class 2 ·Neurology

HEMATACHEK

FDA 510(k)

FDA Class 2 ·Hematology

OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR

FDA 510(k)

FDA Class 2 ·Radiology

CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LIGTHSPEED 3.0 CT SCANNER SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

EsoCheck CCD Cell Collection Device

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SBI AUTOFIX

FDA 510(k)

FDA Class 2 ·Orthopedic

MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay

FDA 510(k)

FDA Class 2 ·Pathology

TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000

FDA 510(k)

FDA Class 2 ·Immunology

CATHETER WITHDRAWAL UNIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Flexitouch Plus System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ADHERENT VISUAL STIMULATOR GOGGLES

FDA 510(k)

FDA Class 2 ·Neurology

MUSCLE MINDER: HEAT WRAP W/ HOT + COLD PACK

FDA 510(k)

FDA Class 2 ·Physical Medicine