OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ProSeal™ Bag Spike with Additive Port (423370ST, 423370)

FDA 510(k)

FDA Class 2 ·General Hospital

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

Ambu Duodeno System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Evis Exera III Duodenovideoscope Olympus TJF-Q190V

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ToxiSeal Vial Adapter with External Balloon

FDA 510(k)

FDA Class 2 ·General Hospital

ToxiSeal™ Vial Adaptor with External Flip Balloon

FDA 510(k)

FDA Class 2 ·General Hospital

Chemfort® Catheter Adaptor

FDA 510(k)

FDA Class 2 ·General Hospital

PENTAX ED-3490TK, VIDEO DUODENOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CRE BALLOON DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD)

FDA 510(k)

FDA Class 2 ·General Hospital

Evis Exera III Duodenovideoscope Olympus TJF-Q190V

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ProSeal™ Vented Universal Vial Adaptor

FDA 510(k)

FDA Class 2 ·General Hospital

Diana ChemoClave Transfer Set

FDA 510(k)

FDA Class 2 ·General Hospital

PENTAX Medical ED34-i10T, Video Duodenoscope

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ProSeal™ Closed System drug Transfer Device (CSTD)

FDA 510(k)

FDA Class 2 ·General Hospital

Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Fujifilm Duodenoscope Model ED-530XT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BD Texium™ Closed Male Luer

FDA 510(k)

FDA Class 2 ·General Hospital