E-FAX SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

E-FAX RECEIVER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KONTRON FAX FETAL MONITOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

E-FAX REMOTE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100

FDA 510(k)

FDA Class 2 ·Anesthesiology

CU-75 VISIBLE LIGHT-CURING UNIT

FDA 510(k)

FDA Class 2 ·Dental

KAI SPOT MODEL KMS 200

FDA 510(k)

FDA Class 2 ·Anesthesiology

MASKS SURGICAL DENTAL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Minjie Catheter System

FDA 510(k)

FDA Class 2 ·Cardiovascular

TECHNICON DAX SYSTEM THYROXINE (T4) METHOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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