BEUDAMED
    47 results · 17ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Open, Classified ×

    BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII Safe ES Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01; Enterprise Server, REF: 1115-00, 134157-01, 137670-02, 134148-01, 135292-01, 136449-01, 133760-01

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code BRY·September 6, 2023

    SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code GEX·December 1, 2023

    muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate

    FDA Recall
    Open, Classified ·Murata Vios, Inc.·Product code DRT·April 22, 2024

    regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009

    FDA Recall
    Open, Classified ·ROi CPS LLC·Product code OEQ·July 24, 2024

    Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2

    FDA Recall
    Open, Classified ·Ambu Inc.·Product code EOQ·December 5, 2023

    Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.

    FDA Recall
    Open, Classified ·AVID Medical, Inc.·Product code LRO·November 11, 2025

    Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.

    FDA Recall
    Open, Classified ·AVID Medical, Inc.·Product code LRO·November 11, 2025

    Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08

    FDA Recall
    Open, Classified ·AVID Medical, Inc.·Product code LRO·November 11, 2025

    HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052, P7501A000053, P7501A000054, P7501A000055, P7501A001851, P7501A001972, P7501A001973, and P7501A001974

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code IOQ·October 4, 2023

    Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.

    FDA Recall
    Open, Classified ·AVID Medical, Inc.·Product code OEZ·March 31, 2025

    Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.

    FDA Recall
    Open, Classified ·AVID Medical, Inc.·Product code OEZ·March 31, 2025

    Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit

    FDA Recall
    Open, Classified ·AVID Medical, Inc.·Product code LRO·March 31, 2025

    Fructosamine Control 1, FR2994 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JJX·December 3, 2018

    Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JIT·December 3, 2018

    Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JJX·December 3, 2018

    FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.

    FDA Recall
    Open, Classified ·I.T.S. GmbH Autal 28 Lasnitzhohe Austria·Product code HRS·January 23, 2026

    Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 70314.

    FDA Recall
    Open, Classified ·I.T.S. GmbH Autal 28 Lasnitzhohe Austria·Product code HRS·January 23, 2026

    Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook Plate; Article Numbers: 21112-7, 21114-5, 21113-9. 2. Olecranon Plate; Article Numbers: 21111-6, 21111-8, 21111-12.

    FDA Recall
    Open, Classified ·I.T.S. GmbH Autal 28 Lasnitzhohe Austria·Product code HRS·January 23, 2026

    Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.

    FDA Recall
    Open, Classified ·I.T.S. GmbH Autal 28 Lasnitzhohe Austria·Product code HRS·January 23, 2026

    Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7. 2. Pilon Plate 4mm; Article Numbers: 21094-10, 21094-4, 21094-6, 21094-8. 3. Pilon Plate, Small; Article Numbers: 21093-4, 21093-6.

    FDA Recall
    Open, Classified ·I.T.S. GmbH Autal 28 Lasnitzhohe Austria·Product code HRS·January 23, 2026