6 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Allura Xper FD20/20; System Code: 722038;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Artis Q.zen ceiling, Model Number 10848354
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025
BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe, Software: V7, REF: 107-223, 107-224, 111-191, 111-192, 111-193, 111-194, 111-195, 111-196, 111-197, 111-198; BD Pyxis CII Safe, Software: V8, 111-199-01, 111-200-01, 111-201-01, 111-202-01, 111-203-01, 111-204-01, 111-205-01, 111-206-01, 107-245-01, 107-246-01; BD Pyxis CII Safe, Software: V9, REF: 107-252-01, 111-215, 111-216, 111-219, 111-221. BD Pyxis CII Safe, Software: ES, REF: 107-254-01, 107-255-01, 1116-00, 1117-00; BD Pyxis CII Safe, Software: N/A, REF: 111-113, 111-114, 111-115, 111-160-201, 111-217, 111-218, 111-220, 111-222; Tripp Lite SUPER6TEL Surge Suppressor, REF: CN 200-025. Used with BD Pyxis CII Safe System: v7.x for WES7 User Guide, DIR 10000145747/ v8.1 User Guide, DIR 10000277635/v9.0 User Guide, DIR 10000354270/ ES User Guide v1.8, DIR 10000418517
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·July 12, 2023
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
ACCOLADE DR EL MRI (Model L331)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025