Panels › Cardiovascular › Product code QNL · Class 2
Medium-Term Adjunctive Predictive Cardiovascular Indicator
Regulation 870.2210
1510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QNL
| Company | 510(k)s | Recalls |
|---|---|---|
| Clew Medical , Ltd. | 2 | 0 |
| Agilemd, Inc. | 1 | 0 |
| Edwards Lifesciences, LLC | 1 | 0 |
| Epic Systems Corporation | 1 | 0 |
| Implicity, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 18, 2026 | K260008 | Deterioration Index Version 2 Epic Systems Corporation | QNL |
| Jun 21, 2024 | K233253 | eCARTv5 Clinical Deterioration Suite (eCART) Agilemd, Inc. | QNL |
| Jan 13, 2024 | K233216 | CLEWICU System Clew Medical , Ltd., IL | QNL |
| Oct 25, 2023 | K230842 | SignalHF (IM008) Implicity, Inc. | QNL |
| Jul 26, 2023 | K231038 | Global Hypoperfusion Index (GHI) Algorithm Edwards Lifesciences, LLC | QNL |
| Jan 9, 2021 | K200717 | CLEWICU System (ClewICUServer and ClewICUnitor) Clew Medical , Ltd., IL | QNL |
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