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

ENDOSCOPIC ULTRASOUND CENTER EU-Y0006

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Balloon Dilator V (with Knife)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F

FDA 510(k)

FDA Class 2 ·Radiology

SYSTEMS INTEGRATION

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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 LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

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

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

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SURGICAL TISSUE MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Single Use Retrieval Nitinol Basket V

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Single Use Aspiration Needle NA-U401SX

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Olympus Small Intestinal Capsule Endoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Olympus Europa SE & Co. KG

Authorized representative

🇩🇪 Germany·6 Manufacturers

DZ 2158445-1

Certificate

MDR QA·OLYMPUS MEDICAL SYSTEMS CORP.·TÜV Rheinland LGA Products GmbH

HZ 2158445-1

Certificate

MDR QMS·OLYMPUS MEDICAL SYSTEMS CORP.·TÜV Rheinland LGA Products GmbH