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

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    Filters Classification: Class Ii ×

    Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·July 16, 2025

    Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is an injector used by patients to inject drugs as prescribed by their doctor.

    FDA Enforcement
    Class II ·Terminated·Owen Mumford USA, Inc.·April 8, 2015

    XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia model) Implant for glaucoma treatment.

    FDA Enforcement
    Class II ·Ongoing·Allergan PLC·December 11, 2019

    REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile

    FDA Enforcement
    Class II ·Terminated·Allergan PLC·February 10, 2021

    NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.

    FDA Enforcement
    Class II ·Ongoing·Nexstim PLC·June 14, 2017

    PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.

    FDA Enforcement
    Class II ·Terminated·PTW-Freiburg·September 2, 2015

    Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.

    FDA Enforcement
    Class II ·Ongoing·Nexstim PLC·June 14, 2017

    Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissue. Product Usage: Single-use device intended for use in open procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic) and minimally invasive arthroscopic procedures where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate tissue. The electrosurgical device is intended for use with conventional monopolar electrosurgical electrodes. Item Code: FT3000F

    FDA Enforcement
    Class II ·Terminated·Covidien, PLC·March 27, 2019

    McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea Code: X3-002-000 (Individual Unit); X3-003-000 (Carton of 10 Units) - Product Usage: is a tool used to aid the intubation of the trachea. As a rigid laryngoscope it holds and shapes the anatomy allowing a clear view of the larynx and entrance to the trachea.

    FDA Enforcement
    Class II ·Ongoing·Medtronic, PLC·March 11, 2020

    Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.

    FDA Enforcement
    Class II ·Ongoing·PTW-FREIBURG·February 28, 2024

    BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using ArrayCal (module from BeamAdjust S080032, UDI-DI: EPTWS0800320 ): " OCTAVIUS Detector 1600 SRS (T10056) (UDI-DI: EPTWT100560) " OCTAVIUS Detector 1600 MR (T10057) (UDI-DI: EPTWT100570) " OCTAVIUS Detector 1600 XDR (T10058) (UDI-DI: EPTWT100580) " OCTAVIUS Detector 1000 SRS (T10036) (UDI-DI: EPTWT100360)

    FDA Enforcement
    Class II ·Ongoing·PTW-FREIBURG·September 20, 2023

    Surgical Kit Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573326 7497-HLS Surgical Kit 573328 7437-NRF SURGICAL ASC KIT 573343 7499-88 SURGICAL KIT with Light Gloves 573346 7499-TLG Surgical Kit with Edge 573359 7499-HLW Surgical KIT 573368 7494-CAB2 SURGICAL KIT 573776 7520-BHP SURGICAL KIT 573777 7527-BHB SURGICAL KITS 573798 7496-8KB Surgical KIT 31144507 7519 Minor Surgical Kit 31175089 7497-8T6 Surgical Kit 31321097 7697 Surgical Set Up Kit 31451480 7493-SFW SURGICAL KIT 31460432 7596-SHH Surgical KIT 50000947 7413-CAD Surgical KIT 50001029 7417-PCP Surgical KIT 50001052 7427-CFS Surgical KIT

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·July 29, 2015

    Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-20-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Rocket Medical Plc·December 24, 2025

    Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Rocket Medical Plc·December 24, 2025

    Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Rocket Medical Plc·December 24, 2025

    Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Rocket Medical Plc·December 24, 2025

    Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Rocket Medical Plc·December 24, 2025

    Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-18-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices.

    FDA Enforcement
    Class II ·Ongoing·Rocket Medical Plc·December 24, 2025

    Rocket KCH Fetal Bladder Drainage Catheter Model: R57405

    FDA Enforcement
    Class II ·Terminated·Rocket Medical Plc·December 4, 2019

    Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032

    FDA Enforcement
    Class II ·Terminated·PTW NORTH AMERICA CORPORATION·January 19, 2022