BEUDAMED
    52 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    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

    Olympus DISPOSABLE GRASPING FORCEPS, FG-51D

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·June 1, 2022

    Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A

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

    Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B

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

    IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·November 19, 2025

    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

    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

    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

    ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

    FDA Enforcement
    Class II ·Completed·Implant Direct Sybron Manufacturing, LLC·January 15, 2020

    ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·October 9, 2019

    ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

    FDA Enforcement
    Class II ·Completed·Implant Direct Sybron Manufacturing, LLC·January 15, 2020

    01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper, per ASTM F138, Amendia, 1755 West Oak Parkway, Marietta, GA 30062 Guide Wires are used to establish a pathway into the bony pedicle to place implants during spinal surgery

    FDA Enforcement
    Class II ·Terminated·Amendia, Inc·May 3, 2017

    Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of both plates and screws used in foot and ankle procedures. Along with a complete range of drivers, the kit also features driver handles and a range of k-wires to assist in removal of cannulated screws. This product is a multiple use, non-sterile instrument.

    FDA Enforcement
    Class II ·Terminated·Wright Medical Technology, Inc.·August 19, 2020

    Screw Removal Case Assembly, Part Number 1985BASE - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of both plates and screws used in foot and ankle procedures. Along with a complete range of drivers, the kit also features driver handles and a range of k-wires to assist in removal of cannulated screws. This product is a multiple use, non-sterile instrument.

    FDA Enforcement
    Class II ·Terminated·Wright Medical Technology, Inc.·August 19, 2020

    ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·October 9, 2019

    Artix MT Thrombectomy Device, REF: 32-102

    FDA Enforcement
    Class II ·Ongoing·Inari Medical - Oak Canyon·May 14, 2025

    AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa Catalog number: KT011. GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods observed on Gram stain. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth. The GNR Traffic Light PNA FISH assay is indicated for use as an aid in the diagnosis of coli, and/or K. pneumoniae, and/or P. aeruginosa bacteremia.

    FDA Enforcement
    Class II ·Terminated·Advandx Inc·October 31, 2012

    Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane

    FDA Enforcement
    Class II ·Ongoing·ACTIM OY·April 24, 2024