BIOMEGA #423-B BLOOD PRESSURE & PULSE CK

FDA 510(k)

FDA Class 2 ·Cardiovascular

EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PURE-AID PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator

FDA 510(k)

FDA Class 2 ·Cardiovascular

IC-2A MRI ADULT/PEDIATRIC VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software

FDA 510(k)

FDA Class 2 ·Hematology

MONARK 869 ERGOMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 298

FDA 510(k)

FDA Class 2 ·Neurology

ACCESS RUBELLA IGG

FDA 510(k)

FDA Class 2 ·Microbiology

EXTERNAL PACEMAKER ANALYZER MODEL PMA-1

FDA 510(k)

FDA Class 2 ·Cardiovascular

SLENDERTONE Evolve Abs, Type 735

FDA 510(k)

FDA Class 2 ·Physical Medicine

SYSTEM-MINI, MODELS: 390, E30

FDA 510(k)

FDA Class 2 ·Physical Medicine

ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Advanced LumFix Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

M-1 PRESSURE MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

Blue Sky Bio Zygomatic Implant System

FDA 510(k)

FDA Class 2 ·Dental

ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Dental