OCTAX LASER SHOT SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HAND HELD DENTAL X-RAY DEVICE

FDA 510(k)

FDA Class 2 ·Radiology

PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INNOFLUOR(TM) PHENOBARBITAL CALIBRATOR SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DCA DIGOX-SYN RIA TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SYRINGE FOR BLOOD SAMPLING

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PREHEPARINZED SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

INNOFLUOR VANCOMYCIN CALIBRATOR SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ALKALINE PHOSPHATASE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

U-100 BAG

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

POLYCARB WATER SET

FDA 510(k)

FDA Class 2 ·Dental

EM-X

FDA 510(k)

FDA Class 2 ·Hematology

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-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 Video Colonoscopes (EC Family)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SIMULIX-MC CT EXTENSION

FDA 510(k)

FDA Class 2 ·Radiology

PENTAX Medical Auto Leakage Tester SHA-P6

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TELHTHERAPY SIMULATOR AECL-CP, G-3200

FDA 510(k)

FDA Class 2 ·Radiology

RESPIRATOR, PROTABLE, VOLUME CONTROLLED

FDA 510(k)

FDA Class 2 ·Anesthesiology