DUNLEE FORMAT COLLIMATOR FAMILY

FDA 510(k)

FDA Class 2 ·Radiology

STORM TDX POWER WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

MODIFICATION TO ACCU-CHEK INFORM METER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BOSS 2000-3 VACUUM ERECTION DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET

FDA 510(k)

FDA Class 2 ·Anesthesiology

OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE)

FDA 510(k)

FDA Class 2 ·Hematology

CD-CHEX + RBC

FDA 510(k)

FDA Class 2 ·Hematology

SPECTRUM VENTRICULAR CATHETER

FDA 510(k)

FDA Class 2 ·Neurology

HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STERIGAGE EO 100%

FDA 510(k)

FDA Class 2 ·General Hospital

DIASTAT VASCULAR ACCESS GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

A & EM MEDICAL ELECTROSURGICAL PENCIL/ACCESSORIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

COMPANION 2800 VOLUME VENTILATOR REMOTE ALARM

FDA 510(k)

FDA Class 2 ·Anesthesiology

CARBAMAZEPINE FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FASGUIDE

FDA 510(k)

FDA Class 2 ·Cardiovascular

7200 MICROPROCESS VENT SYS/MODEL 7202 DISPLAY OPT

FDA 510(k)

FDA Class 2 ·Anesthesiology