ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE)

FDA 510(k)

FDA Class 2 ·Radiology

ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEMODIALYSIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LOCAL REPORT GENERATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

ROTABLATOR, MODIFICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAINSTER WIDE FIELD LASER LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA(

FDA 510(k)

FDA Class 2 ·Immunology

SERAQUEST HSV IGG

FDA 510(k)

FDA Class 2 ·Microbiology

DISPOSABLE PENILE BLOOD PRESSURE CUFFS

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMPLANTABLE TINED, TRANS. PACING LEAD/REVIS. LABEL

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFEPAK 200

FDA 510(k)

FDA Class 2 ·Cardiovascular

LIFEPAK, MODEL 1000

FDA 510(k)

FDA Class 3 ·Cardiovascular

CBC-LINE HEMATOLOGY LINEARITY CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

MODELS 5866-45 AND 5866-46 SIZING SLEEVE

FDA 510(k)

FDA Class 3 ·Cardiovascular

MBI PD-103 SL; MBI PD-103 SH

FDA 510(k)

FDA Class 2 ·Radiology

MODEL 6984M LEAD EXTENDER KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLORIDA PROBE PERIODONTAL PROBE

FDA 510(k)

FDA Class 1 ·Dental

QBC(R) CENTRIFUGAL HEMATOLOGY CONTROL/MULTIPLE

FDA 510(k)

FDA Class 2 ·Hematology

CANUSEAL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

EXSPOR

FDA 510(k)

FDA Class 1 ·General Hospital