BEUDAMED
    38 results · 13ms · Sources: EU EUDAMED, US FDA

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    LOM Disposable Surgical Gowns/Medical Gowns, Single-Use

    FDA Recall
    Open, Classified ·THREAD COUNSEL INC DBA LAWS OF MOTION·Product code FYA·September 17, 2020

    Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator Tube.

    FDA Recall
    Open, Classified ·Elekta Instrument AB Kungstensgatan 18 Stockholm Sweden·Product code HAW·March 15, 2024

    125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB

    FDA Recall
    Open, Classified ·DeVilbiss Healthcare LLC·Product code CAW·September 19, 2022

    DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR

    FDA Recall
    Open, Classified ·DeVilbiss Healthcare LLC·Product code CAW·March 9, 2023

    JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L

    FDA Recall
    Open, Classified ·JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD No·Product code CAW·December 9, 2024

    Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPRO* 1 BLU 150CM GS26 X24 CP-825 SURGIPRO* 2 BLU 150CM GS26 X24 VP-543 SURGIPRO* 2-0 BLU 120CM V20 DA

    FDA Recall
    Open, Classified ·Product code GAW·December 2, 2022

    Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·October 30, 2019

    Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model: 9733763, and StealthStation Cranial, Model: 9735585

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·November 11, 2021

    StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·April 11, 2023

    StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT System, with StealthStation ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT procedures.

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·September 27, 2023

    ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US

    FDA Recall
    Open, Classified ·Ethicon, LLC·Product code GAW·December 20, 2024

    Brand Name: Leksell Vantage Arc System REF: 1053958

    FDA Recall
    Open, Classified ·Elekta, Inc.·Product code HAW·March 19, 2026

    DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q

    FDA Recall
    Open, Classified ·DeVilbiss Healthcare LLC·Product code CAW·November 18, 2022

    NaviNetics Skull Anchor Key and Drill Kit, REF NN1215

    FDA Recall
    Open, Classified ·Navinetics Inc·Product code HAW·February 26, 2024

    Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref : 6143.1834S

    FDA Recall
    Open, Classified ·Globus Medical, Inc.·Product code HAW·December 11, 2023

    Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund Catheter Insertion Needle Kit III; (2) Part #A2800-15, Backlund Catheter Insertion Needle Kit I; (3) Part #A2600-01, Backlund Haematoma Evacuator Kit; (4) Part #A2200-01, Salcman Twist Drill Kit I; (5) Part #907801, Insertion Cannula Kit; (6) Part #50398-01, Catheter Inserter Needle 1,5; (7) Part #307165, Insertion Cannula 190 MM; (8) Part #60377-02, Twist Drill 3.2 MM; (9) Part #60377-01, Twist Drill 2.1 MM; (10) Part #50376-01, Salcman Twist Drill 2.1/3.2; (11) Part #14001050, Catheter Inserter Needle 2,6; and (12) Part #1002248, Frame G w Straight/Curved Front.

    FDA Recall
    Open, Classified ·Elekta Instrument AB Kungstensgatan 18 Stockholm Sweden·Product code HAW·March 1, 2023

    iGo2 DC Car Adapter to be used with iGo2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.

    FDA Recall
    Open, Classified ·Medical Depot Inc.·Product code CAW·April 11, 2025

    Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1870S

    FDA Recall
    Open, Classified ·Globus Medical, Inc.·Product code HAW·December 11, 2023

    GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S

    FDA Recall
    Open, Classified ·Ohio Medical Corporation·Product code CAW·May 8, 2025

    PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.

    FDA Recall
    Open, Classified ·Ethicon, LLC·Product code GAW·December 20, 2024