BEUDAMED
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    IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida

    FDA Recall
    Open, Classified ·IMPRIS Imaging Inc·Product code LNH·September 30, 2025

    IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio

    FDA Recall
    Open, Classified ·IMPRIS Imaging Inc·Product code LNH·September 30, 2025

    Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.

    FDA Recall
    Open, Classified ·Mobius Imaging, LLC·Product code JAK·December 4, 2025

    MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.

    FDA Recall
    Open, Classified ·Mobius Imaging, LLC·Product code JAK·December 7, 2022

    Snapshot NIR, REF: KD204

    FDA Recall
    Open, Classified ·KENT IMAGING, INC.·Product code MUD·October 30, 2023

    Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600 Software Version: Not Applicable Product Description: The HFD100 Head Fixation Device provides rigid skeletal fixation within the optimal imaging envelope while introducing minimal artifacts in the acquired images. There are two different assemblies for the HFD100. The standard HFD100 is equipped with a table adapter for use with either the operating room table or the angiography table. For sites with a Hill-Rom TruSystem 7500 Hybrid Neuro MR Operating Table (ORT400), the HFD100 has a split block clamp assembly (Trumpf Mount Clamp Assembly) which connects directly to the table back section. The HFD100 system is also comprised of the linkage components to mount the skull clamp to the table adapter, and the 3-pin skull clamp. The linkage system is used to position the skull clamp in the necessary position, without colliding with the magnet bore. Component: Not a component.

    FDA Recall
    Open, Classified ·IMRIS Imaging Inc·Product code HBL·December 8, 2025

    IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra

    FDA Recall
    Open, Classified ·IMPRIS Imaging Inc·Product code LNH·September 30, 2025

    Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.

    FDA Recall
    Open, Classified ·Mobius Imaging, LLC·Product code JAK·December 4, 2025

    IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA

    FDA Recall
    Open, Classified ·IMPRIS Imaging Inc·Product code LNH·September 30, 2025

    Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085

    FDA Recall
    Open, Classified ·Omega Medical Imaging, Inc.·Product code IWE·September 8, 2023

    Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085

    FDA Recall
    Open, Classified ·Omega Medical Imaging, Inc.·Product code IWE·February 28, 2023

    North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. Industrial x-ray imaging of product hardware

    FDA Recall
    Open, Classified ·North Star Imaging Inc·Product code RCE·August 23, 2017

    Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)

    FDA Recall
    Open, Classified ·Given Imaging Ltd. New Industrial Park·Product code FFT·June 3, 2025

    BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication through one or two different ports via an IV cannula or extension tube. The ports can be used to sample blood or for hemodynamic monitoring. When used with IV lipid nutritional products, the stopcock device can be used for up to 24 hours.

    FDA Recall
    Open, Classified ·Product code FMG·May 21, 2026

    6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code FMG·August 1, 2022

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. IV ADMIN SET, 10 DROPS/ML, 144 IN; Catalog Number: 490385. 2. IV ADMIN SET, 3 CARESITES, 120 IN.; Catalog Number: 490401.

    FDA Recall
    Open, Classified ·B Braun Medical Inc·Product code FMG·October 29, 2025

    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8537

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FMG·August 29, 2025

    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meters). Non-DEHP, Product Code 2R8519

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FMG·August 29, 2025

    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 120-inch (3.0 meters), Non-DEHP, Product Code 2R8537

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FMG·August 29, 2025

    CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer Activated Valve, Pfoduct code 2C6255

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FMG·August 29, 2025