ENDOSCOPE REPROCESSOR OER-Elite

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Single Use Biliary Balloon Dilator

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MONOCHROME LCD MONITOR, RADIFORCE MODEL GS310

FDA 510(k)

FDA Class 2 ·Radiology

Rhino-Laryngo Videoscope Olympus ENF-VT3

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Visera Elite II Video System Center

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Single Use Aspiration Needle NA-U200H

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

THUNDERBEAT Open Fine Jaw

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

COLOR LCD MONITOR, RADIFORCE RX320

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Balloon Dilator V (with Knife)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Luer-Split MAJ-2092

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F

FDA 510(k)

FDA Class 2 ·Radiology

RADIFORCE GX220 AND GS220 MONOCHROME LCD MONITORS

FDA 510(k)

FDA Class 2 ·Radiology

THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type X

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OLYMPUS URF-V2/V2R

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MONOCHROME LCD MONITOR, MODEL RADIFORCE GX320

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology