Spacelabs Healthcare, Ltd.
5 FDA 510(k) clearances · Recalling firm
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| Record | Firm | Date |
|---|---|---|
| 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.