BACTTRAP

FDA 510(k)

FDA Class 2 ·Anesthesiology

GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VASCUTEK VASCULAR PROSTHESES, EXTRA SOFT/LOW WOVEN

FDA 510(k)

FDA Class 2 ·Cardiovascular

HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COBE HEMODYNAMIC RECIRCULATION MONITOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

InThrill™ Thrombectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

SWANK ARTERIAL LINE BLOOD FILTER HF6000

FDA 510(k)

FDA Class 2 ·Cardiovascular

GAMBRO FH 66 D HEMOFILTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INSIGHT IMAGE GUIDED SURGICAL SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000

FDA 510(k)

FDA Class 2 ·Radiology

HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MINIVASIVE LAPAROSCOPY INSTRUMENTS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COBE AIR EMBOLI PROTECTION SYSTEM (AEPS)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CRK CONDYLAR RESURFACING TOTAL KNEE

FDA 510(k)

FDA Class 2 ·Orthopedic

COBE CENTRY 2 BICART OPTION KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MYRINGOTOMY TUBE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)

FDA Class 2 ·Microbiology

OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)

FDA Class 2 ·Microbiology