SUPRAPUBIC CATHETER AND INTRODUCER SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NON-CONTACT FOREHEAD INFRARED THERMOMETER, MODEL DT-8806H, BODY INFRARED THERMOMETER, MODEL DT-8806 AND DIGITAL INFRARED

FDA 510(k)

FDA Class 2 ·General Hospital

PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Sparse Sample Pk Profile And Dosing Software

FDA classification

FDA Class 2 ·Sparse Sample Pk Profile And Dosing Software

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

Panendoscope (Gastroduodenoscope)

FDA classification

FDA Class 2 ·Panendoscope (Gastroduodenoscope)

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