BAYER IMMUNO 1 HER-2/NEU ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Her-2, ER, PR IHControls

FDA 510(k)

FDA Class 2 ·Hematology

MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)

FDA 510(k)

FDA Class 2 ·Immunology

BAYER ADVIA CENTAUR HER-2/NEU ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

RESPOND(R) Ventilator

FDA 510(k)

FDA Class 2 ·Anesthesiology

NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS

FDA 510(k)

FDA Class 2 ·Anesthesiology

FOUNDATION HYBRID COMPOSITE

FDA 510(k)

FDA Class 2 ·Dental

REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE

FDA 510(k)

FDA Class 2 ·Orthopedic

AVC A/H5N1 FLU TEST

FDA 510(k)

FDA Class 2 ·Microbiology

UST-665P-5, UST-664-5/7.5, ASU-35WL-10, SCU-35

FDA 510(k)

FDA Class 2 ·Radiology

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·MEDSTONE STS(TM) LITHOTRIPTER

X-Y Lubricating Jelly

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LAITEST Medical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ALOKA SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS ASU-1003, UST-9121, UST-9124

FDA 510(k)

FDA Class 2 ·Radiology

BETACHEK GLUCOSE TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HEATING TENS/EMS, FT-810R

FDA 510(k)

FDA Class 2 ·Neurology

Veloxion System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MD211C3 21.3 DIAGNOSTIC IMAGING LCD MONITOR

FDA 510(k)

FDA Class 2 ·Radiology