3 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Phoenix mKDR, digital mobile diagnostic x-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·March 8, 2023
Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-200-010
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·November 15, 2023
BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA00020, Q6660E-PA00011, 6660E-PA00021, 6660E-PA00016, 6660E-PA00019, Q6660E-PA00018, 6660E-PA00010, Q6660E-PA00010, Q6660E-PA00021, Q6660E-PA00012, 6660E-PA00030, 6660E-PA00041, 6660E-PA00035, 6660E-PA00032, 6660E-PA00031. Software Versions: 1.04.00.01, 01.05.00.01, 01.06.00.01, and 01.06.01.01 The patient monitor is intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.
FDA Enforcement
Class II
·Ongoing·Mindray DS USA, Inc. dba Mindray North America·October 1, 2025