SURGITRON RADIOLASE II

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TOXOPLASMA IGM MICROASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

Yooeehouse Breast Pump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GMC Upper Arm Automatic Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

AXXENT RADIATION SHIELD - RIGID

FDA 510(k)

FDA Class 2 ·Radiology

ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350

FDA 510(k)

FDA Class 2 ·Cardiovascular

QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System

FDA 510(k)

FDA Class 2 ·Medical Genetics

Digital Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

RII INFRARED EAR THERMOMETER, MODELS TH5XY SERIES

FDA 510(k)

FDA Class 2 ·General Hospital

DI ISOLATION GOWN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GMX Series Medical Air/Oxygen Blender

FDA 510(k)

FDA Class 2 ·Anesthesiology

SAFFRON NM GUIDING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Monitoring System Goodlife AC-30

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AXXENT FLEXISHIELD MINI

FDA 510(k)

FDA Class 2 ·Radiology

Infant Incubator

FDA 510(k)

FDA Class 2 ·General Hospital

Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses

FDA 510(k)

FDA Class 2 ·Ophthalmic

UNISIGHT SYSTEM WITH UNIGATE

FDA 510(k)

FDA Class 2 ·Radiology

MAGBODY DT-600

FDA 510(k)

FDA Class 2 ·Neurology

Paclitaxel Sets

FDA 510(k)

FDA Class 2 ·General Hospital