FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Linkt Compression Staple System

FDA 510(k)

FDA Class 2 ·Orthopedic

CombiSet Hemodialysis Blood Tubing Set

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NMI PICC II

FDA 510(k)

FDA Class 2 ·General Hospital

EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

I-PLANT, MODEL 3500

FDA 510(k)

FDA Class 2 ·Radiology

MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

DATEX-OHMEDA HMEF 500

FDA 510(k)

FDA Class 2 ·Anesthesiology

RENEGADE STC 18 MICROCATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM)

FDA 510(k)

FDA Class 2 ·Dental

HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS

FDA 510(k)

FDA Class 2 ·Radiology

LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

SDI SB OFFICE, MODEL 29-

FDA 510(k)

FDA Class 2 ·Anesthesiology

Force Fiber OrthoTape suture

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Z3 GUIDE CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

LIFESPAN EPTFE VASCULAR GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

Tactoset

FDA 510(k)

FDA Class 2 ·Orthopedic

S-ROM HIP SYSTEM - LOCKING PLUG

FDA 510(k)

FDA Class 2 ·Orthopedic

MONTG. LARYNGEAL KEEL

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat