King Systems Corp. dba Ambu, Inc.
Medical device manufacturer in Noblesville, IN.
0510(k) clearances
0PMA approvals
11recalls
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0276-2025 Class II | KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx…Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication… | 09/26/2024Open, Classified |
| Z-0275-2025 Class II | KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx…Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication… | 09/26/2024Open, Classified |
| Z-0274-2025 Class II | KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx…Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication… | 09/26/2024Open, Classified |
| Z-0273-2025 Class II | KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx…Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication… | 09/26/2024Open, Classified |
| Z-0272-2025 Class II | KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the…Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication… | 09/26/2024Open, Classified |
| Z-0271-2025 Class II | KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the…Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication… | 09/26/2024Open, Classified |
| Z-0270-2025 Class II | KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the…Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication… | 09/26/2024Open, Classified |
| Z-0269-2025 Class II | AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx…Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication… | 09/26/2024Open, Classified |
| Z-0916-2020 Class I | King Vision Video Adapter Size 1/2. Laryngoscope used to examine and visualize a…Exhibiting a reversed image. Although the image may appear normal, the users actions will be reversed on the… | 11/05/2019Terminated |
| Z-1681-2019 Class II | King LTS-D Kit Size 1, Model Number KLTSD431Size 0 products were incorrectly packaged and labeled as a size 1 products. | 01/04/2019Terminated |
| Z-0321-2018 Class II | UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z, D390-6121Z…Potential for leak test failures. | 03/15/2017Terminated |