ATI DISPOSABLE BIOLOGICAL-PLUS TEST PACK

FDA 510(k)

FDA Class 2 ·General Hospital

SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842

FDA 510(k)

FDA Class 2 ·Neurology

CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

HealthJOINT

FDA 510(k)

FDA Class 2 ·Radiology

PANOPTIC

FDA 510(k)

FDA Class 2 ·Ophthalmic

XCHF-T160 VIDEOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MALIS IRRIGATION MODULE 1000

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SHUN-THAI - SAFE-CONTACT, BOSTON MEDICAL LATEX EXAM GLOVE, SHUN-THAI LATEX EXMINATION GLOVE

FDA 510(k)

FDA Class 1 ·General Hospital

ZEUS MALE CONDOM APPLICATOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ELECSYS PRECICONTROL TROPONIN T

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve

FDA 510(k)

FDA Class 2 ·Orthopedic

LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

SPACELABS MEDICAL MULTIPARAMETER MODULE 91496

FDA 510(k)

FDA Class 2 ·Cardiovascular

GE DATEX-OHMEDA AVANCE CS2

FDA 510(k)

FDA Class 2 ·Anesthesiology

DVFX, MODEL M256

FDA 510(k)

FDA Class 2 ·Radiology

EAGLESOFT CHAIRSIDE

FDA 510(k)

FDA Class 2 ·Radiology

BUN, MODEL BU 104-01

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SARNS VISIFLOW AORTIC ARCH CANNULA

FDA 510(k)

FDA Class 2 ·Cardiovascular

TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology