Ambu A/S
Ballerup, DK
Ambu A/S appears in FDA device records in Ballerup, DK. FDA records list 27 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 27
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 27 510(k) clearances for Ambu A/S between 2016 and 2026. The busiest year on record is 2024, with 7. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 3 |
| 2018 | 2 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 5 |
| 2024 | 7 |
| 2025 | 1 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | Substantially Equivalent | |
| K251583 | Ambu® Virobac II® Exhalation Filter | CAH | Substantially Equivalent | |
| K250269 | Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection) | FAJ | Substantially Equivalent | |
| K240849 | Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2 | FAJ | Substantially Equivalent | |
| K240848 | Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aView™ 2 Advance | FAJ | Substantially Equivalent | |
| K242108 | Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aView™ 2 Advance | FGB | Substantially Equivalent | |
| K233630 | Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aBox™ 2 | FGB | Substantially Equivalent | |
| K233886 | Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2 | FDT | Substantially Equivalent | |
| K232919 | Ambu® aScope™ Gastro Large; Ambu® aBox™ 2 | FDS | Substantially Equivalent | |
| K233671 | Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 Advance | EOQ | Substantially Equivalent | |
| K232582 | Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set | EOQ | Substantially Equivalent | |
| K230332 | Ambu® aScope™ Colon; Ambu® aBox™ 2 | FDF | Substantially Equivalent | |
| K230428 | Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2 | EOQ | Substantially Equivalent | |
| K223299 | Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance | EOQ | Substantially Equivalent | |
| K223782 | Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set | EOQ | Substantially Equivalent | |
| K220606 | Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2 | EOQ | Substantially Equivalent | |
| K212382 | Ambu® aScope™ Gastro, Ambu® aBox™2 | FDS | Substantially Equivalent | |
| K210883 | aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8 | EOQ | Substantially Equivalent | |
| K203749 | Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable | CBI | Substantially Equivalent | |
| K193095 | Ambu aScope 4 Cysto | FAJ | Substantially Equivalent | |
| K190972 | Ambu aScope 4 RhinoLaryngo Intervention | EOB | Substantially Equivalent | |
| K191080 | Ambu aScope 4 RhinoLaryngo Slim | EOB | Substantially Equivalent | |
| K181286 | Ambu aScope RLS Slim | EOB | Substantially Equivalent | |
| K173727 | Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor | EOQ | Substantially Equivalent | |
| K161656 | Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor | EOQ | Substantially Equivalent | |
| K152931 | Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator | BTM | Substantially Equivalent | |
| K160766 | Ambu USR, Ambu M | FAJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- EOQBronchoscope (Flexible Or Rigid)
- FDFColonoscope And Accessories, Flexible/Rigid
- FAJCystoscope And Accessories, Flexible/Rigid
- FDTDuodenoscope And Accessories, Flexible/Rigid
- GXYElectrode, Cutaneous
- CAHFilter, Bacterial, Breathing-Circuit
- FDSGastroscope And Accessories, Flexible/Rigid
- EOBNasopharyngoscope (Flexible Or Rigid)
- CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
- FGBUreteroscope And Accessories, Flexible/Rigid
- BTMVentilator, Emergency, Manual (Resuscitator)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain