5 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
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EasyPoint Needle, 25G x 5/8", REF: 82091
FDA Enforcement
Class II
·Ongoing·Retractable Technologies, Inc.·March 20, 2024
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·October 5, 2022
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025