35 results
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21ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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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