DOCTORS REVIEW SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

SD-970EMS ELECTRICAL MUSCULAR STIMULATOR

FDA 510(k)

FDA Class 2 ·Physical Medicine

SD-956 ULTRASOUND THERAPY

FDA 510(k)

FDA Class 2 ·Physical Medicine

GB-1002 TENS WITH MASSAGE

FDA 510(k)

FDA Class 2 ·Neurology

SD-730 IF-SDS, PERFECT PULSE IF-SDS

FDA 510(k)

FDA Class 2 ·Neurology

SD-100 SKYEAR THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD)

FDA 510(k)

FDA Class 2 ·Neurology

CONDUCTIVE GEL FOR ULTRASOUND

FDA 510(k)

FDA Class 2 ·Neurology

YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP-600J

FDA 510(k)

FDA Class 2 ·Cardiovascular

SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

BATCH #6060 CONDUCTIVE GEL

FDA 510(k)

FDA Class 2 ·Neurology

IF-727 INTERFERENTIAL STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

BD PEN NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)

FDA 510(k)

FDA Class 2 ·Microbiology

BD VACUTAINER PLUS PST II TUBE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml

FDA 510(k)

FDA Class 2 ·Microbiology

PAXGENE BLOOD RNA SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO PAXGENE BLOOD RNA SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology