Ambu A/S
FDA 510(k) & PMA Approved Devices — 27 products
Total Devices27
Categories11
Latest FDA decision2026-07-14
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K260578 | Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US) | GXY | 2026-07-14 | View |
| 510(k) | K251583 | Ambu® Virobac II® Exhalation Filter | CAH | 2026-04-30 | View |
| 510(k) | K250269 | Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection) | FAJ | 2025-06-11 | View |
| 510(k) | K240849 | Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2 | FAJ | 2024-10-16 | View |
| 510(k) | K240848 | Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aView™ 2 Advance | FAJ | 2024-10-10 | View |
| 510(k) | K242108 | Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aView™ 2 Advance | FGB | 2024-08-16 | View |
| 510(k) | K233630 | Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aBox™ 2 | FGB | 2024-06-24 | View |
| 510(k) | K233886 | Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2 | FDT | 2024-04-16 | View |
| 510(k) | K232919 | Ambu® aScope™ Gastro Large; Ambu® aBox™ 2 | FDS | 2024-04-05 | View |
| 510(k) | K233671 | Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 Advance | EOQ | 2024-01-04 | View |
| 510(k) | K232582 | Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set | EOQ | 2023-09-20 | View |
| 510(k) | K230332 | Ambu® aScope™ Colon; Ambu® aBox™ 2 | FDF | 2023-09-15 | View |
| 510(k) | K230428 | Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2 | EOQ | 2023-08-10 | View |
| 510(k) | K223299 | Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance | EOQ | 2023-06-01 | View |
| 510(k) | K223782 | Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set | EOQ | 2023-01-12 | View |
| 510(k) | K220606 | Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2 | EOQ | 2022-07-25 | View |
| 510(k) | K212382 | Ambu® aScope™ Gastro, Ambu® aBox™2 | FDS | 2022-02-03 | View |
| 510(k) | K210883 | aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8 | EOQ | 2021-06-17 | View |
| 510(k) | K203749 | Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable | CBI | 2021-05-03 | View |
| 510(k) | K193095 | Ambu aScope 4 Cysto | FAJ | 2020-04-02 | View |
No matching devices.
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