Ambu, Inc.
Medical device manufacturer in Columbia, MD.
33510(k) clearances
0PMA approvals
11recalls
Device types
- BTM Ventilator, Emergency, Manual (Resuscitator) 15
- BYE Attachment, Breathing, Positive End… 2
- GXY Electrode, Cutaneous 2
- DRX Electrode, Electrocardiograph 2
- CAI Circuit, Breathing (W Connector, Adaptor, Y… 1
- BWF Spirometer, Therapeutic (Incentive) 1
- GCY Apparatus, Suction, Single Patient Use… 1
- BTL Ventilator, Emergency, Powered (Resuscitator) 1
- BSJ Mask, Gas, Anesthetic 1
- BTA Pump, Portable, Aspiration (Manual Or… 1
- BTR Tube, Tracheal (W/Wo Connector) 1
- CAF Nebulizer (Direct Patient Interface) 1
- BSY Catheters, Suction, Tracheobronchial 1
- MGQ Dressing, Wound And Burn, Hydrogel W/Drug… 1
- MKJ Automated External Defibrillators… 1
- CAP Monitor, Airway Pressure (Includes Gauge… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K051529 | Ambu Neuroline GroundGXY · Traditional | 08/04/2005SE |
| K042682 | Ambu Spur Ii. Adult Single Patient ResuscitatorBTM · Traditional | 11/15/2004SE |
| K042843 | Ambu Spur II Infant and Pediatric Single Patient Use ResuscitatorsBTM · Traditional | 11/12/2004SE |
| K041734 | Ambu Disposable ECG ElectrodeDRX · Traditional | 09/22/2004SE |
| K040991 | Ambu Disposable Pressure ManometerCAP · Traditional | 07/22/2004SE |
| K041026 | Ambu Blue Sensor, MRX, ECG Electrode Product #:MRX-00-SDRX · Traditional | 06/28/2004SE |
| K032278 | Ambu Neuroline Single Patient Eeg/Ep Cup ElectrodeGXY · Traditional | 03/05/2004SE |
| K032421 | Ambu Pediatric Multi-Function Defibrillation ElectrodeMKJ · Traditional | 02/27/2004SE |
| K010583 | Ambu Gel, Hydrogel Burn DressingMGQ · Traditional | 05/25/2001SE |
| K993278 | Ambu Neonate Silicone ResuscitatorBTM · Traditional | 05/17/2000SE |
| K992902 | Ambu Hand Power Suction PumpBSY · Traditional | 10/25/1999SE |
| K982722 | Ambu Medibag Adult, Ambu Medibag Infant/ChildCAF · Traditional | 04/12/1999SE |
| K981891 | Ambu TubecheckBTR · Traditional | 07/17/1998SE |
| K964584 | Ambu Spur NeonateBTM · Traditional | 05/15/1997SE |
| K932031 | Ambu Portable Suction UnitBTA · Traditional | 05/05/1995SE |
| K932014 | Ambu Disposable Face MaskBSJ · Traditional | 06/22/1993SE |
| K923762 | Spur Infant/Child W/O Pressure-Limiting ValveBTM · Traditional | 02/05/1993SE |
| K923976 | Ambu Single Patient Use Peep ValveBYE · Traditional | 01/05/1993SE |
| K924216 | Ambu Silicone Resuscitator Infan/Child W/Open ResoBTM · Traditional | 09/16/1992SE |
| K924215 | Ambu Silicone Resuscitator, Adult W/Open ReservoirBTM · Traditional | 09/16/1992SE |
| K922712 | Spur Infant/Child with Open Reservoir SystemBTM · Traditional | 06/19/1992SE |
| K922707 | Spur Adult with Open Reservoir SystemBTM · Traditional | 06/19/1992SE |
| K914187 | Ambu Silicone Resuscitator Infant/ChildBTM · Traditional | 10/07/1991SE |
| K910040 | Ambu Sir 2 (Silicone Resuscitator), AdultBTM · Traditional | 05/28/1991SE |
| K904920 | Ambu Matic Automatic ResuscitatorBTL · Traditional | 05/28/1991SE |
| K902261 | Ambu Spur (Single Patient Use Resuscitator) InfantBTM · Traditional | 07/16/1990SE |
| K900260 | Ambu Life Key and Ambu Res-Cue KeyBTM · Traditional | 06/08/1990SE |
| K883434 | Ambu Spur (Single Patient Use Resuscitator)BTM · Traditional | 09/14/1988SE |
| K883433 | Ambu Twin Pump - (Manual Suction Pump)GCY · Traditional | 09/02/1988SE |
| K873579 | Ambu RMT ValveBWF · Traditional | 12/30/1987SE |
| K851194 | Ambu CPAP SystemBYE · Traditional | 04/15/1985SE |
| K844149 | Ambu Ruben Circle Anesthesia SystemCAI · Traditional | 11/15/1984SE |
| K840349 | Mark III ResuscitatorBTM · Traditional | 02/10/1984SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2181-2025 Class I | Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog…Potential for the manometer port being blocked rendering the manometer non-functional. | 07/09/2025Open, Classified |
| Z-1723-2025 Class II | Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000USIncorrect labeling in which the front red pouch label did not match the actual size of the medical device.… | 04/07/2025Open, Classified |
| Z-0261-2025 Class II | Ambu VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr…Ambu has received complaints on Ambu VivaSight 2 DLTs regarding hyper angulation of the distal end. The… | 09/16/2024Open, Classified |
| Z-0714-2024 Class II | Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2Instructions for Use have been updated to add the following warning: Use only M4 screws with the length of… | 12/05/2023Open, Classified |
| Z-2628-2023 Class II | Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data…Multiple impacts, for example from being dropped, can cause to the Ambu aView 2 Advance to short-circuit and… | 07/21/2023Open, Classified |
| Z-1420-2022 Class II | Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and…Firm has received complaints on the device concerning leak/rupture of either the bronchial or tracheal cuff.… | 06/03/2022Open, Classified |
| Z-1236-2016 Class II | Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face…Ambu, Aura Gain laryngeal Mask, was found to have lack of Sterility Assurance. The firm discovered the… | 02/10/2016Terminated |
| Z-0536-2008 | Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve Spare Part, REF 137 000…Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow… | 08/21/2007Terminated |
| Z-0535-2008 | Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, 30mm…Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow… | 08/21/2007Terminated |
| Z-0534-2008 | Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, REF 000…Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow… | 08/21/2007Terminated |
| Z-0533-2008 | Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 30 mm, REF 000 137…Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow… | 08/21/2007Terminated |