PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INTERMITTENT PNEUMATIC COMPRESSION DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

U.V. Method, Cpk Isoenzymes

FDA classification

FDA Class 2 ·U.V. Method, Cpk Isoenzymes

Chromatographic Separation, Cpk Isoenzymes

FDA classification

FDA Class 2 ·Chromatographic Separation, Cpk Isoenzymes

Tubing, Fluid Delivery

FDA classification

FDA Class 2 ·Tubing, Fluid Delivery

Liquid Chromatography, Morphine

FDA classification

FDA Class 2 ·Liquid Chromatography, Morphine

Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241

FDA 510(k)

FDA Class 2 ·General Hospital

Biosensor, Immunoassay, Cpk Or Isoenzymes

FDA classification

FDA Class 2 ·Biosensor, Immunoassay, Cpk Or Isoenzymes

Colorimetric Method, Cpk Or Isoenzymes

FDA classification

FDA Class 2 ·Colorimetric Method, Cpk Or Isoenzymes

Fluorometric Method, Cpk Or Isoenzymes

FDA classification

FDA Class 2 ·Fluorometric Method, Cpk Or Isoenzymes

Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CO2 Laser Machine (Lume)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NIRO-200NX

FDA 510(k)

FDA Class 2 ·Cardiovascular

P300 Attachment

FDA 510(k)

FDA Class 2 ·Neurology

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5

FDA 510(k)

FDA Class 2 ·Radiology

Estelite Universal Flow

FDA 510(k)

FDA Class 2 ·Dental

FUJIFILM Endoscope Model EG-530N

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

XIDF-AWS801, Angio Workstation, V7.0

FDA 510(k)

FDA Class 2 ·Radiology

Image Filing Software NAVIS-EX

FDA 510(k)

FDA Class 2 ·Radiology