BEUDAMED
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    X-Guide Handpiece Adaptor Sleeve 3, Model P010727

    FDA Recall
    Open, Classified ·X-NAV Technologies, LLC·Product code QRY·March 4, 2024

    X-Guide Handpiece Adaptor Sleeve 1, Model P010701

    FDA Recall
    Open, Classified ·X-NAV Technologies, LLC·Product code QRY·March 4, 2024

    X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673

    FDA Recall
    Open, Classified ·X-NAV Technologies, LLC·Product code QRY·September 28, 2022

    Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generate projection X-Ray images of human patients. Models: 5411/ 050, A5411/ 0300 and A5411/ 0400

    FDA Recall
    Open, Classified ·Agfa N.V. Septestraat 27 Mortsel Belgium·Product code IZL·February 23, 2024

    DR 800. Digital Radiography X-ray System.

    FDA Recall
    Open, Classified ·Agfa N.V. Septestraat 27 Mortsel Belgium·Product code JAA·July 29, 2024

    Barco MDSC-8527 NXF, Part Number K9352421

    FDA Recall
    Open, Classified ·Barco N.V. President Kennedypark 35 Kortrijk Belgium·Product code KQM·December 20, 2023

    Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H/K9306220; and MNA-640: MNA-640 DEC -H/K9306410, MNA-640 ENC -H/K9306420; components of the NexxisOR system

    FDA Recall
    Open, Classified ·Barco N.V. President Kennedypark 35 Kortrijk Belgium·Product code DXJ·May 9, 2025

    V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.

    FDA Recall
    Open, Classified ·Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands·Product code JJF·January 18, 2016

    V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180

    FDA Recall
    Open, Classified ·Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands·Product code JJF·November 15, 2018

    Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data . Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8.1, 8.1.1, 8.1.2, 8.1.3,8.1.4, 8.2.0.000, 8.2.1.000, 8.2.2.000, 8.3.0.000, 8.3.1.000, 8.3.2.000, 8.4.0.000, 8.4.1.000 (including all SU s and HF s)

    FDA Recall
    Open, Classified ·Agfa Healthcare NV Septestraat 27 Mortsel Belgium·Product code LLZ·September 6, 2024

    Agfa HealthCare Enterprise Imaging XERO Viewer

    FDA Recall
    Open, Classified ·Agfa Healthcare NV Septestraat 27 Mortsel Belgium·Product code LLZ·December 5, 2022

    Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental

    FDA Recall
    Open, Classified ·Preat Corp·Product code NHA·July 18, 2023

    Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;

    FDA Recall
    Open, Classified ·Straumann USA LLC·Product code NHA·March 17, 2026

    ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETRGA4544MP

    FDA Recall
    Open, Classified ·Hiossen Inc.·Product code NHA·January 27, 2025

    Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETMTA503RV1

    FDA Recall
    Open, Classified ·Hiossen Inc.·Product code NHA·January 27, 2025

    9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

    FDA Recall
    Open, Classified ·Preat Corp·Product code NHA·April 10, 2024

    ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETRGA4524MP

    FDA Recall
    Open, Classified ·Hiossen Inc.·Product code NHA·January 27, 2025

    Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Model/Catalog Number: 70-1047-COM0117

    FDA Recall
    Open, Classified ·Prismatik Dentalcraft, Inc.·Product code NHA·September 30, 2025

    Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;

    FDA Recall
    Open, Classified ·Straumann USA LLC·Product code NHA·March 17, 2026

    Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETMTA505RV1

    FDA Recall
    Open, Classified ·Hiossen Inc.·Product code NHA·January 27, 2025