Company · DK
Ambu A/S
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2026. Name variants (Inc, Corp, punctuation) are merged.
41510(k) clearances (4 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | 11 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 5 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 4 |
| DRX | Electrode, Electrocardiograph | 3 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 3 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 3 |
| BTR | Tube, Tracheal (W/Wo Connector) | 2 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 2 |
| IKT | Electrode, Needle, Diagnostic Electromyograph | 2 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 |
| CBI | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | 1 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 1 |
| FDT | Duodenoscope And Accessories, Flexible/Rigid | 1 |
| GXY | Electrode, Cutaneous | 1 |
| GXZ | Electrode, Needle | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 16, 2026 | K261400 | Ambu® aScope Gastro; Ambu® aScope Gastro Large Ambu A/S, DK | FDS |
| Sep 16, 2026 | K260309 | Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set Ambu A/S, DK | EOQ |
| Jul 14, 2026 | K260578 | Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set Ambu A/S, DK | GXY |
| Apr 30, 2026 | K251583 | Ambu® Virobac II® Exhalation Filter Ambu A/S, DK | CAH |
| Jun 11, 2025 | K250269 | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection) Ambu A/S, DK | FAJ |
| Oct 16, 2024 | K240849 | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aBox 2 Ambu A/S, DK | FAJ |
| Oct 10, 2024 | K240848 | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aView 2 Advance Ambu A/S, DK | FAJ |
| Aug 16, 2024 | K242108 | Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aView 2 Advance Ambu A/S, DK | FGB |
| Jun 24, 2024 | K233630 | Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aBox 2 Ambu A/S, DK | FGB |
| Apr 16, 2024 | K233886 | Ambu® aScope Duodeno 2, Ambu® aBox 2 Ambu A/S, DK | FDT |
| Apr 5, 2024 | K232919 | Ambu® aScope Gastro Large; Ambu® aBox 2 Ambu A/S, DK | FDS |
| Jan 4, 2024 | K233671 | Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aView 2 Advance Ambu A/S, DK | EOQ |
| Sep 20, 2023 | K232582 | Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set Ambu A/S, DK | EOQ |
| Sep 15, 2023 | K230332 | Ambu® aScope Colon; Ambu® aBox 2 Ambu A/S, DK | FDF |
| Aug 10, 2023 | K230428 | Ambu® aScope 5 Broncho 2.7/1.2, Ambu® aScope 5 Broncho 4.2/2.2, Ambu® aBox 2 Ambu A/S, DK | EOQ |
| Jun 1, 2023 | K223299 | Ambu® aScope 5 Broncho HD 5.0/2.2, Ambu® aScope 5 Broncho HD 5.6/2.8, Ambu® aView 2 Advance Ambu A/S, DK | EOQ |
| Jan 12, 2023 | K223782 | Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set Ambu A/S, DK | EOQ |
| Jul 25, 2022 | K220606 | Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2 Ambu A/S, DK | EOQ |
| Feb 3, 2022 | K212382 | Ambu® aScope Gastro, Ambu® aBox2 Ambu A/S, DK | FDS |
| Jun 17, 2021 | K210883 | aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8 Ambu A/S, DK | EOQ |
| May 3, 2021 | K203749 | Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable Ambu A/S, DK | CBI |
| Apr 2, 2020 | K193095 | Ambu aScope 4 Cysto Ambu A/S, DK | FAJ |
| Jul 12, 2019 | K190972 | Ambu aScope 4 RhinoLaryngo Intervention Ambu A/S, DK | EOB |
| May 22, 2019 | K191080 | Ambu aScope 4 RhinoLaryngo Slim Ambu A/S, DK | EOB |
| Nov 30, 2018 | K181286 | Ambu aScope RLS Slim Ambu A/S, DK | EOB |
| Mar 28, 2018 | 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 Bronc Ambu A/S, DK | EOQ |
| Sep 1, 2016 | 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 Ambu A/S, DK | EOQ |
| Aug 29, 2016 | K152931 | Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator Ambu A/S, DK | BTM |
| Aug 17, 2016 | K160766 | Ambu USR, Ambu M Ambu A/S, DK | FAJ |
| Nov 1, 2013 | K130845 | AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW Ambu A/S | EOQ |
| Nov 18, 2011 | K110962 | AMBU ASCOPE 2 Ambu A/S | BTR |
| Jan 28, 2011 | K102824 | AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC Ambu A/S | BTM |
| Jun 11, 2010 | K100129 | AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X Ambu A/S | DRX |
| Apr 16, 2010 | K093186 | AMBU ASCOPE AND MONITOR Ambu A/S | BTR |
| Jan 13, 2010 | K093825 | AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE Ambu A/S | IKT |
| Jul 30, 2007 | K071186 | MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE Ambu A/S | IKT |
| May 30, 2007 | K071185 | MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE Ambu A/S | GXZ |
| Oct 25, 2006 | K053550 | AMBU BLUE SENSOR NEO AND NEO X Ambu A/S | DRX |
| Oct 25, 2006 | K052944 | AMBU WHITE SENSOR CFM, CFL Ambu A/S | DRX |
| Dec 23, 2005 | K053140 | AMBU MARK IV RESUSCITATOR Ambu A/S | BTM |
| Dec 20, 2005 | K053142 | AMBU MARK IV BABY RESUSCITATOR Ambu A/S | BTM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||