45 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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MAGNETOM Cima.X Upgrade. Model Number: 11689304.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·November 19, 2025
Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories. The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
FDA Enforcement
Class I
·Terminated·Baxter Healthcare Corp·November 12, 2014
Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixture Products and Accessories The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
FDA Enforcement
Class I
·Terminated·Baxter Healthcare Corp·November 12, 2014
IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA
FDA Enforcement
Class I
·Ongoing·IMPRIS Imaging Inc·November 5, 2025
IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida
FDA Enforcement
Class I
·Ongoing·IMPRIS Imaging Inc·November 5, 2025
IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra
FDA Enforcement
Class I
·Ongoing·IMPRIS Imaging Inc·November 5, 2025
IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio
FDA Enforcement
Class I
·Ongoing·IMPRIS Imaging Inc·November 5, 2025
Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·May 20, 2026
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·May 20, 2026
Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·May 20, 2026
SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696
FDA Enforcement
Class I
·Terminated·Becton Dickinson & Company·July 3, 2019
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducer
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·May 20, 2026
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·May 20, 2026
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·May 20, 2026
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducer
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·May 20, 2026
Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·September 25, 2024
Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·September 25, 2024
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·September 25, 2024
Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·September 25, 2024
MAGNETOM Connectom.X. Model Number: 11371480.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025