ALERE PBP2A TEST

FDA 510(k)

FDA Class 2 ·Microbiology

POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN

FDA 510(k)

FDA Class 2 ·Immunology

CELLERATION MIST THERAPY SYSTEM 5.1

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEPARIN ASSAY CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

TrapLiner catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Reprocessed ViewFlex™ Xtra ICE Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ILLUMISITE Platform

FDA 510(k)

FDA Class 2 ·Radiology

WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER

FDA 510(k)

FDA Class 2 ·Anesthesiology

Aequalis Flex Revive Shoulder System

FDA 510(k)

FDA Class 2 ·Orthopedic

EVERSHEARS(R) SCISSORS, BILAP(R) PROBES, BICOAG(R) FORCEPS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VITREA IMAGE DENOISING SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

VENTREX COATED TUBE T3 UPTAKE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OptiMap™ System

FDA 510(k)

FDA Class 2 ·Cardiovascular

SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO PTA CATH

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDGRAPHICS PF/DX

FDA 510(k)

FDA Class 2 ·Anesthesiology

MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD

FDA 510(k)

FDA Class 2 ·Cardiovascular