TORAY SUPERSELECTIVE GUIDEWIRES, ADDITIONAL TYPES

FDA 510(k)

FDA Class 2 ·Cardiovascular

Facial Toning device (UIC-189); Facial Toning device (UIC-589)

FDA 510(k)

FDA Class 2 ·Neurology

INTERACOUSTICS COMPUTER AUDIOMETER BA 20

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

WINGED INFUSION SET A-PORT VASCULAR ACCESS SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

Lung-CAD

FDA 510(k)

FDA Class 2 ·Radiology

Bashir S-B Endovascular Catheter, Ref. No. 7101

FDA 510(k)

FDA Class 2 ·Cardiovascular

Spine Navigation System

FDA 510(k)

FDA Class 2 ·Neurology

COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA.

FDA 510(k)

FDA Class 2 ·Microbiology

KELYNIAM CUSTOM SKULL IMPLANT (CSI)

FDA 510(k)

FDA Class 2 ·Neurology

EMI MODEL FFF-IA

FDA 510(k)

FDA Class 2 ·Cardiovascular

Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices

FDA 510(k)

FDA Class 2 ·General Hospital

ClearCalc Model RADCA V2

FDA 510(k)

FDA Class 2 ·Radiology

TRANSFER SET

FDA 510(k)

FDA Class 2 ·General Hospital

NeuroEEG

FDA 510(k)

FDA Class 2 ·Neurology

CLEARFIL CORE NEW BOND

FDA 510(k)

FDA Class 2 ·Dental

SBI WRISTFIT

FDA 510(k)

FDA Class 2 ·Orthopedic

Ambra PACS

FDA 510(k)

FDA Class 2 ·Radiology

OUR ROTATING GAMMA SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

EASTGATE PERSONAL MONITOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SUR-FIT IRRIGATION SLEEVE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology