Olympus America Inc.

Model: TJF-Q180V, all sold units

Gastroenterology-Urology Devices

2

No

Worldwide Distribution: US (nationwide) and countries of: Canada and Mexico.

EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. || This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

All sold units

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA (nationwide) including Puerto Rico and Internationally to Canada.

TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC: THUNDERBEAT 5 mm, 35 em, Inline Grip TB-0520IC: THUNDERBEAT 5 mm, 20 em, In line Grip TB-051 OIC: THUNDERBEAT 5 mm, I 0 em, In line Grip || TB-545FC: THUNDERBEAT 5 mm, 45 em, Front Actuated Grip || TB-0535FC: THUNDERBEAT 5 mm, 35 em, Front Actuated Grip || The Olympus Thunderbeat Surgical Tissue Management System ("Thunderbeat") is intended to be used for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.

Models: NA-201SX-4022-A --22 gauge needle: all lot numbers; NA-201SX-4022-B --22 gauge needle: all lot numbers; NA-201SX-4022-C --22 gauge needle: all lot numbers; and NA-201SX-4021 -- 21 gauge needle: all lot numbers.

Gastroenterology-Urology Devices

2

No

Nationwide Distribution including the District of Columbia and the following States: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY.

OLYMPUS ViziShot EBUS Aspiration Needle || Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.

Serial numbers 11053P230001, 11053P230002, 11053P230003, 11053P230004, 11053P230005, 11060P230001, 11160P230002, 11060P230003, 11160P230004, 11160P230005, 11081P230001, 11081P230003, 11081P230004, 11081P230005, 11081P230006, 11081P230007, 11081P230008, 11081P230009, 11081P230010, 11094P230006, 11094P230007, 11094P230008, 11094P230009, 11094P230010, 11096P230007, 11096P230008, 11096P230009, 11096P230010, 11102P230001, 11102P230002, 11102P230003, 11102P230004, 11102P230005, 11109P230002, 11109P230003, 11109P230004, 11109P230005, 11110P230001, 11110P230002, 11110P230003, 11110P230004, 11110P230005, 11116P230001, 11116P230002, 11116P230003, 11116P230004, 11116P230005, 11117P230001, 11117P230002, 11117P230003, 11117P230004, 11117P230005, 11132P230001, 11132P230002, 11132P230003, 11132P230004, 11132P230005, 11133P230001, 11133P230002, 11133P230003, 11138P230002, 11138P230003, 11138P230004, 11139P230001, 11139P230002, 11139P230005, 11167P230001, 11167P230004, 11180P230003, 11180P230005, 11201P230005, 11201P230010, 11202P230001, 11202P230005, 25456W23-101, 25456W23-102, 25456W23-107, 25456W23-108, 25456W23-109, 25522W23-101, 25522W23-102, 25522W23-103, 25522W23-104, 25522W23-105, 25553W23-105, 25553W23-107, 25553W23-108, 25553W23-109, 25553W23-110, 25565W23-102, 25565W23-103, 25565W23-105, 25565W23-106, 25565W23-108, 25565W23-109, 25565W23-110, 25593W23-101, 25593W23-102, 25593W23-103, 25593W23-104, 25593W23-105, 25593W23-107, 25593W23-109, 25593W23-110, 25607W23-101, 25607W23-102, 25607W23-103, 25607W23-104, 25607W23-105, 25607W23-106, 25607W23-107, 25607W23-108, 25607W23-110, 25613W23-101, 25613W23-102, 25613W23-103, 25613W23-104, 25613W23-105, 25613W23-106, 25613W23-107, 25613W23-108, 25613W23-109, 25613W23-110, 25686W23-102, 25719W23-105, 25719W23-106, 25736W23-101, 25736W23-102, 25736W23-103, 25736W23-104, 25736W23-105, 25736W23-106, 25736W23-107, 25736W23-108, 25736W23-109, 25752W23-101, 25752W23-102, 25752W23-103, 25752W23-104, 25752W23-105, 25752W23-106, 25752W23-107, 25776W23-101, 25776W23-102, 25776W23-103, 25776W23-105, 25776W23-106, 25776W23-107, 25776W23-108, 25776W23-109, 25776W23-110, 25869W23-101, 25869W23-102, 25869W23-103, 25869W23-104, 25869W23-105, 25869W23-106, 25869W23-107, 25869W23-108, 25869W23-109, 25869W23-110, 25978W23-104, 25978W23-105, 25978W23-106, 25978W23-107, 26052W23-109, 26052W23-110, 26085W23-101, 26085W23-102, 26085W23-103, 26085W23-104, 26085W23-105, 26085W23-106, 26085W23-107, 26085W23-108, 26085W23-109, 26136W23-101, 26136W23-103, 26136W23-104, 26136W23-105, 26136W23-107, 26136W23-108, 26136W23-109, 26136W23-110, 26162W23-108, 26162W23-109, 26162W23-110, 26227W23-102, 26227W23-103, 26227W23-104, 26227W23-105, 26227W23-106, 26227W23-107, 26227W23-108, 26227W23-109, 26227W23-110, 26456W23-101, 26456W23-102, 26456W23-103, 26456W23-104, 26456W23-105, 26456W23-106, 26456W23-107, 26456W23-108, 26456W23-109, 26456W23-110, 26559W23-101, 26559W23-103, 26559W23-104, 26559W23-105, 26559W23-108, 26559W23-109, 26559W23-110, 26710W23-108, 26710W23-109, 26770W23-101, 26770W23-102, 26770W23-103, 26770W23-104, 26770W23-105, 26770W23-106, 26770W23-107, 26770W23-108, 26770W23-109, 26770W23-110, 26878W23-101, 26878W23-102, 26878W23-103, 26878W23-104, 26878W23-105, 26879W23-102, 26879W23-103, 26879W23-104, 26879W23-105, 26917W23-101, 26917W23-102, 26917W23-103, 26917W23-105, 26917W23-106, 26917W23-107, 26917W23-108, 26917W23-109, 26917W23-110, and 26992W23-110.

General and Plastic Surgery Devices

2

No

Nationwide Distribution.

Olympus Electrosurgical Unit. || The Olympus Electrosurgical Unit (ESG-100) is used in conjunction with cutting and coagulation electrosurgical devices intended for use in electrosurgery procedures during flexible gastrointestinal endoscopy.

Catalog number 7501669

Gastroenterology-Urology Devices

2

No

Nationwide distribution: USA including states of: AL, AK, AZ, AR, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, AND WY.

Olympus OFP Flushing Pump irrigation tubing || The Olympus OFP Flushing Pump is a peristaltic flushing pump intended for use with Olympus gastrointestinal videoscopes having an auxiliary water inlet as part of an Olympus endoscopic imaging system to facilitate washing of gastric and colonic mucosa to remove blood, feces and other organic matter, enabling improved visualization, diagnosis and therapy during endoscopic procedures.