ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Alternate Controller Enabled Insulin Infusion Pump

FDA classification

FDA Class 2 ·Alternate Controller Enabled Insulin Infusion Pump

DRY LASER IMAGER, MODEL DRYPRO MODEL 793

FDA 510(k)

FDA Class 2 ·Radiology

20.1 MONOCHROME LCD MONITOR, RADIFORCE G20

FDA 510(k)

FDA Class 2 ·Radiology

DIRECT DIGITIZER, REGIUS MODEL 190

FDA 510(k)

FDA Class 2 ·Radiology

REGIUS RS-1000, MEDICAL IMAGE PROCESSING WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72

FDA 510(k)

FDA Class 2 ·Hematology

Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument

FDA 510(k)

FDA Class 2 ·Microbiology

PURITAN FOAM TIP SWAB MODEL 2197

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit

FDA 510(k)

FDA Class 2 ·Microbiology

SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN

FDA 510(k)

FDA Class 2 ·Immunology

Multi Modality Viewer

FDA 510(k)

FDA Class 2 ·Radiology

Alere i Instrument, Alere i Influenza A & B, Alere i Strep A

FDA 510(k)

FDA Class 2 ·Clinical Chemistry