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

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

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

Endoilluminator, Reprocessed

FDA classification

FDA Class 2 ·Endoilluminator, Reprocessed

Flow Cytometric Test System For Hematopoietic Neoplasms

FDA classification

FDA Class 2 ·Flow Cytometric Test System For Hematopoietic Neoplasms

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

Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

FDA classification

FDA Class 2 ·Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

Differential Rate Kinetic Method, Cpk Or Isoenzymes

FDA classification

FDA Class 2 ·Differential Rate Kinetic Method, Cpk Or Isoenzymes

Device, Dental Sonography, For Diagnosis Of Tmj / Mpd Disorders

FDA classification

FDA Class 2 ·Device, Dental Sonography, For Diagnosis Of Tmj / Mpd Disorders

Device, Jaw Tracking, For Diagnosis Of Tmj / Mpd Disorders

FDA classification

FDA Class 2 ·Device, Jaw Tracking, For Diagnosis Of Tmj / Mpd Disorders

Sparse Sample Pk Profile And Dosing Software

FDA classification

FDA Class 2 ·Sparse Sample Pk Profile And Dosing Software