Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED PTCA CATHETER

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

PRISMAFLEX

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PHOENIX HEMODIALYSIS DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

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

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

PRISMAFLEX M150 SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Mosaic (V1.0.1)

FDA 510(k)

FDA Class 2 ·Radiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACE(TM) AND LONG ACE(TM) MODELS

ROSE K POST GRAFT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

ZenPro 40

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry