EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

URODYNAMIC CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CARDIO REP LD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NEUROLOGICAL LEADS (PACKAGING MODIFICATION)

FDA 510(k)

FDA Class 2 ·Neurology

PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22994

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VIDEO SIGMOIDOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DOBBHOFF BIPOLAR ADAPTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

O.R./SURGEONS GOWN, ITEM NO. 4951

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CHRONODYNAMICS DATA RECORDER (CDR)-100

FDA 510(k)

FDA Class 2 ·General Hospital

ARTHRO-TRAC(TM)

FDA 510(k)

FDA Class 2 ·Orthopedic

STERILE INSTRUMENT DRAPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACUSON I7505 TRANSDUCER FOR INTRACAVITARY APPLICA.

FDA 510(k)

FDA Class 2 ·Radiology

ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES

FDA 510(k)

FDA Class 2 ·Radiology

PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED

FDA 510(k)

FDA Class 2 ·Cardiovascular

GOLD CORE POST SOLDER

FDA 510(k)

FDA Class 2 ·Dental

MEMFIX SCREWS

FDA 510(k)

FDA Class 2 ·Dental

BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

PHILIPS BV26 MOBILE C-ARM STAND

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO ZILVER 635 BILIARY STENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology