THYROXINE ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DEXIS SENSOR

FDA 510(k)

FDA Class 2 ·Dental

COHORT(TM) ANTERIOR PLATE SYSTEM (APS)

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)

FDA 510(k)

FDA Class 2 ·Hematology

Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System

FDA 510(k)

FDA Class 2 ·Microbiology

StrataMR Valves and Shunts

FDA 510(k)

FDA Class 2 ·Neurology

LIDO V-TAK

FDA 510(k)

FDA Class 2 ·Physical Medicine

CREATININE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SEQUENCER

FDA 510(k)

FDA Class 2 ·Radiology

ECHOSCAN, MODEL US-1800

FDA 510(k)

FDA Class 2 ·Radiology

TRUEBEAM

FDA 510(k)

FDA Class 2 ·Radiology

TWINLOOK

FDA 510(k)

FDA Class 2 ·Dental

NuVasive® CoRoent® Thoracolumbar System

FDA 510(k)

FDA Class 2 ·Orthopedic

BARCOMED 2MP2

FDA 510(k)

FDA Class 2 ·Radiology

FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25

FDA 510(k)

FDA Class 2 ·Hematology

MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942

FDA 510(k)

FDA Class 2 ·Cardiovascular

IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

KSEA N2O ENDOFLATOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LightStim Professional 2-Panel Light

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery