40 results
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17ms
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Sources: EU EUDAMED, US FDA
MAGNETOM Cima.X Upgrade. Model Number: 11689304.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·November 19, 2025
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
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
BIOGRAPH One (DE). Model Number: 11689172.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY CATH LAB, Medline Kit Number/SKUDYNJ23532C; 2. CATH LAB PACK, Medline Kit Number/SKUDYNJ65185; 3. ANGIO KIT, Medline Kit Number/SKUVASC1057.
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·May 20, 2026