Company
King Systems Corp. dba Ambu, Inc.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2024 | King Systems Corp. dba Ambu, Inc. KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway.
Model/Catalog Number: KKLTSD4325 Open, Classified |
CAE | None listed |
| Oct 30, 2024 | King Systems Corp. dba Ambu, Inc. KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway.
Model/Catalog Number: KLTSD432 Open, Classified |
CAE | None listed |
| Oct 30, 2024 | King Systems Corp. dba Ambu, Inc. KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD431 Open, Classified |
CAE | None listed |
| Oct 30, 2024 | King Systems Corp. dba Ambu, Inc. KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway.
Model/Catalog Number: KLTSD430 Open, Classified |
CAE | None listed |
| Oct 30, 2024 | King Systems Corp. dba Ambu, Inc. KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway.
Model/Catalog Number: KLTSD4225 Open, Classified |
CAE | None listed |
| Oct 30, 2024 | King Systems Corp. dba Ambu, Inc. KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway.
Model/Catalog Number: KLTSD422 Open, Classified |
CAE | None listed |
| Oct 30, 2024 | King Systems Corp. dba Ambu, Inc. KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway.
Model/Catalog Number: KLTSD421 Open, Classified |
CAE | None listed |
| Oct 30, 2024 | King Systems Corp. dba Ambu, Inc. AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway.
Model/Catalog Number: KLTSD420 Open, Classified |
CAE | None listed |
| Feb 4, 2020 | King Systems Corp. dba Ambu, Inc. King Vision Video Adapter Size 1/2. Laryngoscope used to examine and visualize a patients upper airway and aid in the placement of a tracheal tube.
Model Number: KVLVA12 Terminated |
CCW | None listed |
| Jan 4, 2019 | King Systems Corp. dba Ambu, Inc. King LTS-D Kit Size 1, Model Number KLTSD431 Terminated |
CAE | None listed |
| Mar 15, 2017 | King Systems Corp. dba Ambu, Inc. UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z, D390-6121Z, D495-61Z, DF4116-6121Z, D466-61Z, DFP170-6121, DF3115-6121Z, DF375-6121Z, DF3115-6121Z, DF3115-6121Z, D360-8031Z, D Terminated |
CAH | K973797 |