CASSETTE TAPE REPLAY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EMIT CONVENIENCE PACK: THYROXINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MICROTRAK CMV CULTURE CONFIRMATION TEST

FDA 510(k)

FDA Class 2 ·Microbiology

XEMEX ENTERAL NUTRITION CATHETER NASOGAS. TYPE A

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ARTHREX INSTRUMENTS (BASIC)

FDA 510(k)

FDA Class 2 ·Orthopedic

DRAPES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MICROAIR FLUIDIZED AIR BED

FDA 510(k)

FDA Class 2 ·Physical Medicine

IDENTI LOOPS DEGANIA SILICONE

FDA 510(k)

FDA Class 2 ·Cardiovascular

EMIT D.A.U. LOW AND MEDIUM CALIBRATORS B

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

IV EXTENSION SETS WITH .22 MICRON FILTER

FDA 510(k)

FDA Class 2 ·General Hospital

AIRCAST VENAFLOW SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CRACK-IT CHAP SCREEN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PATIENT DATA MANAGEMENT SYSTEM (PROJECT 735)

FDA 510(k)

FDA Class 2 ·Radiology

SPLASH SHIELD # 4505, 4507, PARASHIELD # 4509

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

POLARIX 2 AND POLARIX 2E

FDA 510(k)

FDA Class 2 ·Radiology

EMIT(R) II CALIBRATOR A LEVEL 1 & LEVEL 2

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

IL TEST COMPLEMENT 4

FDA 510(k)

FDA Class 2 ·Immunology

IL TEST BILIRUBIN TOTAL/DIRECT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry