Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·CLARIS(TM) REWETTING DROPS

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·QVCAD SYSTEM

BICART

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DRYASOL ACID CONCENTRATE MIX

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DRI-LYTE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PRISMASATE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HEMO-DIAL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FRESENIUS BIOCARB HEMODIALYSIS GRADE SODIUM BICARB

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PreOp

FDA 510(k)

FDA Class 2 ·Neurology

SODIUM BICARBONATE, U.S.P.

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NXSTAGE PUREFLOW SOLUTION

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CITRISOL ACID CONCENTRATE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACETATE-FREE DIALYSLATE SOLUTION

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ALTHIN MEDICAL AB ALTRACART II

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ELEKTA OY

FDA 510(k)

FDA Class 2 ·Neurology

HEMOD CONCE OF VAR FORMU & LIPUID HEMOD CONCE ADD

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PrismaSATE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology