UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO GLOBALCARDIO

FDA 510(k)

FDA Class 2 ·Cardiovascular

Endotoxin Activity Assay (EAA)

FDA 510(k)

FDA Class 2 ·Microbiology

XPLORER 1600

FDA 510(k)

FDA Class 2 ·Radiology

IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR

FDA 510(k)

FDA Class 2 ·Radiology

SIMPLER MINI DENTAL IMPLANT: SM 3002 2.5 X 10MM, SM 3003 2.5 X 13MM, SM 3004 2.5 X 15MM

FDA 510(k)

FDA Class 2 ·Dental

Clarius Ultrasound Scanner

FDA 510(k)

FDA Class 2 ·Radiology

HARMONIE SENSA

FDA 510(k)

FDA Class 2 ·Neurology

The Panthera Anti-Snoring X3 Device

FDA 510(k)

FDA Class 2 ·Dental

O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES

FDA 510(k)

FDA Class 2 ·Ophthalmic

ISOCAM I (SINGLE HEAD GAMMA CAMERA)/ISOCAM II (DUAL HEAD GAMMA CAMERA)

FDA 510(k)

FDA Class 2 ·Radiology

CAS PSI KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SNN SCOUT

FDA 510(k)

FDA Class 2 ·Neurology

SYREX SYRINGE

FDA 510(k)

FDA Class 2 ·Dental

FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE

FDA 510(k)

FDA Class 2 ·General Hospital

EVANS, VAS-CATH EPIDURAL NEEDLE & CATHETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

SYRINGE PUMP: VM 07

FDA 510(k)

FDA Class 2 ·General Hospital

Combined Aerobika OPEP and VersaPAP device

FDA 510(k)

FDA Class 2 ·Anesthesiology

4.0MM SIMPLER THREADED DENTAL IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30

FDA 510(k)

FDA Class 2 ·Clinical Chemistry