BEUDAMED
    437 results · 23ms · Sources: EU EUDAMED, US FDA

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    Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code GEX·February 27, 2026

    Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of the uterine cavity. Part# 54298-10/pack

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code HHI·September 12, 2019

    Colonoscope, Model Number PCF-H190DL.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code NWB·January 11, 2024

    Colonoscope, Model Number CF-HQ190L.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FDF·January 11, 2024

    POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0523CJDA

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code GEI·March 7, 2024

    EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FDF·September 14, 2023

    Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications. Component: No

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code GEX·April 4, 2025

    Duravent Silicone Ventilation Tube. Model Number: 240075.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code ETD·November 19, 2024

    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5424110 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code LFL·November 25, 2024

    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423430 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code LFL·November 25, 2024

    EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code EOQ·September 11, 2025

    EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code EOQ·September 11, 2025

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FEB·March 25, 2026

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FEB·March 25, 2026

    Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Model/Catalog Number: TFL-FBX150R, TFL-FBX200R, TFL-FBX365R, TFL-FBX550R, TFL-FBX940R, TFL-FBX940R-JA (Japan Only), TFL-FBX365R-JA (Japan Only), TFL-FBX200BS-JA (Japan Only), TFL-FBX150R-JA (Japan Only), TFL-FBX200R-JA (Japan Only), TFL-FBX550R-JA (Japan Only); Product Description: SOLTIVE Laser Fibers are delivery devices that transmit laser energy from the laser console to the treatment site through the fiber tip. The laser connector secures the device to the laser.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code GEX·May 6, 2025

    Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS Cutting Forceps are intended to be passed through a 5 mm laparoscopic cannula. Coagulation is achieved using electrosurgical energy under laparoscopic visualization. The device is intended to be used with the Gyrus ACMI G400 Workstation only.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code GEI·February 25, 2026

    Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FJL·November 11, 2025

    Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code LFL·October 22, 2025

    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code KNS·January 7, 2026