AUTOMIX 3+3/AS COMPOUNDER SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM TOTAL PSA

CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02

FDA 510(k)

FDA Class 2 ·Cardiovascular

EXALIS, SOFTWARE VERSION 1.15

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MOLECULAR ADSORBENT RECIRCULATING(MARS)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WEBSTER DUO-DECAPOLAR CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRISMAFLEX

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CAD/CAMouflage Milling Block

FDA 510(k)

FDA Class 2 ·Dental

SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05

FDA 510(k)

FDA Class 2 ·Cardiovascular

WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04,

FDA 510(k)

FDA Class 2 ·Cardiovascular

PHOENIX HEMODIALYSIS DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Delta 3300

FDA 510(k)

FDA Class 2 ·Cardiovascular

MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106

FDA 510(k)

FDA Class 2 ·Cardiovascular

GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRISMAFLEX SYSTEM 7.10

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology