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Spacelabs Healthcare, Ltd.

5 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software V recall (Z-0416-2026)Spacelabs Healthcare, Ltd.2025-10-31
Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder recall (Z-0684-2025)Spacelabs Healthcare, Ltd.2024-12-17
Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous recall (Z-0685-2025)Spacelabs Healthcare, Ltd.2024-12-17
Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 6 recall (Z-2589-2018)Spacelabs Healthcare, Ltd.2018-08-10
Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 0 recall (Z-0072-2018)Spacelabs Healthcare, Ltd.2017-11-21

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Every clearance here is in the API, with alerts when new ones post.