System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC

HIVOX SPOPAD EMS

FDA 510(k)

FDA Class 2 ·Physical Medicine

KLS-MARTIN TEMPORARY CONDYLAR IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HEATING TENS/EMS, FT-810R

FDA 510(k)

FDA Class 2 ·Neurology

ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15

FDA 510(k)

FDA Class 2 ·Dental

OPXION Optical Skin Viewer (OPXSV1-01F)

FDA 510(k)

FDA Class 2 ·Radiology

Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series

FDA 510(k)

FDA Class 2 ·Anesthesiology

OXLIFE

FDA 510(k)

FDA Class 2 ·Anesthesiology

AViTA Pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

FORA DIAMOND NEXUS MINI INFRARED FOREHEAD THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

VOLUMETRIC INCENTIVE SPIROMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

Wrist Type Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100

FDA 510(k)

FDA Class 2 ·Cardiovascular

HIVOX SELF ADHESIVE ELECTRODE GEL PADS

FDA 510(k)

FDA Class 2 ·Neurology

LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

CAREGIVER PROFESSIONAL CLINICAL THERMOMETER, PRO-TF SERIES

FDA 510(k)

FDA Class 2 ·General Hospital

LELTEK Ultrasound Imaging System (Model: LU700 Series)

FDA 510(k)

FDA Class 2 ·Radiology

PURILENS SALINE SOLUTION

FDA 510(k)

FDA Class 2 ·Ophthalmic

DIGITAL THERMOMTER

FDA 510(k)

FDA Class 2 ·General Hospital