VT·One, VT·One 60days

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MSI TA ELECTRODES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRO-FLEX, DIGITAL THERMOMETER WITH FLEXIBLE PROBE

FDA 510(k)

FDA Class 2 ·General Hospital

“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)

FDA 510(k)

FDA Class 2 ·Neurology

“BRAXX” Esophageal Brachytherapy Applicator

FDA 510(k)

FDA Class 2 ·Radiology

PACI-TEMP, PACIFIER WITH DIGITAL THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

RUMBLE TUFF

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MSI SA ELECTRODES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Rumble Tuff Electric Breast Pump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O

FDA 510(k)

FDA Class 2 ·Cardiovascular

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·artus CMV RGQ MDx Kit and artus CMV QS-RGO MDx Kit

BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software

FDA 510(k)

FDA Class 2 ·Cardiovascular

FUNET AMY MAMA BODY THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

BioXmark

FDA 510(k)

FDA Class 2 ·Radiology

Hydrozid

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SONON Ultrasound Imaging System, Model: 300L

FDA 510(k)

FDA Class 2 ·Radiology

SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry