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Ambu Inc.

6 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number recall (Z-2181-2025)Ambu Inc.2025-08-13
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US recall (Z-1723-2025)Ambu Inc.2025-05-06
Ambu VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog recall (Z-0261-2025)Ambu Inc.2024-10-30
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2 recall (Z-0714-2024)Ambu Inc.2024-01-11
Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data f recall (Z-2628-2023)Ambu Inc.2023-09-22
Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face m recall (Z-1236-2016)Ambu Inc.2016-03-24

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Every clearance here is in the API, with alerts when new ones post.