ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Millipede 088 Access Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

LABELING CHANGE - VIASPAN(TM) (BELZER UW)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO XYLOS SURGICAL MESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BMR FACE

FDA 510(k)

FDA Class 2 ·Neurology

AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9511C

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MUELLER HINTON AGAR WITH 2% NACI

FDA 510(k)

FDA Class 2 ·Microbiology

DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets

FDA 510(k)

FDA Class 2 ·Orthopedic

UROVYSION BLADDER CANCER RECURRENCE KIT

FDA 510(k)

FDA Class 2 ·Immunology

PF4 ENHANCED SOLID PHASE ELISA

FDA 510(k)

FDA Class 2 ·Hematology

SYSTEM-ARMS, MODELS 390, X60

FDA 510(k)

FDA Class 2 ·Physical Medicine

HYDROTONE I

FDA 510(k)

FDA Class 2 ·Physical Medicine

M71 POWER WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

CATHLINK 20 TITANIUM PORT W/ATT. POLYURETHANE CATH

FDA 510(k)

FDA Class 2 ·General Hospital

PREDICTOR HOME PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CRC PC Smart Chamber K1

FDA 510(k)

FDA Class 2 ·Radiology

BACT/ALERT 120

FDA 510(k)

FDA Class 1 ·Microbiology

VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CMD/DLCO DIAGNOSTIC SPIROMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry