BEUDAMED
    7 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·February 11, 2026

    Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·February 11, 2026

    Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012

    FDA Enforcement
    Class II ·Ongoing·Aomori Olympus Co., Ltd.·September 13, 2023

    LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used with Olympus endoscope for crushing calculi inside the bile duct.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·January 22, 2025

    Medline Convenience kits labeled as: 1) KIT, MIDSTREAM, W/BZK/FUNNL,3O, Pack Number DYND30212; 2) PROCESSING KIT 3 PTE0000204 , Pack Number DYNJ65728A ; 3) 30ML KIT, Pack Number DYNJ82155A ; 4) DISSECTION, Pack Number DYNJ85191; 5) FLAP HARVEST PACK , Pack Number DYNJ58575C ; 6) KIT, MIDSTREAM, W/BZK/FUNNL,3O, Pack Number DYND30212H ; 7) FLAP HARVEST PACK, Pack Number DYNJ58575C

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.B

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·June 28, 2023

    Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.A

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·June 28, 2023