Pure Vu System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ProMIS™ Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

D2P

FDA 510(k)

FDA Class 2 ·Radiology

IVENT101

FDA 510(k)

FDA Class 2 ·Anesthesiology

X100 with Full Field Peripheral Blood Smear (PBS) Application

FDA 510(k)

FDA Class 2 ·Hematology

HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO VELASMOOTH, SHAPER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIODEX ACT-O-KIT TSH-RIA-

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NovaCross Microcatheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

OSSIX VOLUMAX

FDA 510(k)

FDA Class 2 ·Dental

PRESTODR PORTABLE

FDA 510(k)

FDA Class 2 ·Radiology

EARLYSENSE CENTRAL DISPLAY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Vibrant System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Neteera 130H/131H Vital Sign Monitoring Sensor

FDA 510(k)

FDA Class 2 ·Cardiovascular

CorSens

FDA 510(k)

FDA Class 2 ·Cardiovascular

ZIDA Wearable Neuromodulation System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MIS V3 Conical Connection Dental Implant System­

FDA 510(k)

FDA Class 2 ·Dental

POLESTAR N-20

FDA 510(k)

FDA Class 2 ·Radiology

SOLO MICROPUMP INSULIN DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital