Company
Bunnell, 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)
5recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LSZ | Ventilator, High Frequency | 5 |
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) |
|---|---|---|---|
| Dec 3, 2022 | Bunnell, Inc. 2.5 mm LifePort Endotracheal Tube Adapters 10-pack, Catalog: 9025; and 2.5 mm LifePort Endotracheal Tube Adaptors inside Patient Circuit Kits, Catalog: 938 Open, Classified |
LSZ | None listed |
| Dec 14, 2012 | Bunnell, Inc. Patient Circuit used with the Life Pulse High Frequency Ventilator. The Patient Circuit is a required disposable component of the Life Pulse High Frequency Ventilator.
Model #(s):
Individual Patient Terminated |
LSZ | None listed |
| Jan 14, 2011 | Bunnell, Inc. One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203, Manufactured by: Bunnell Incorporated Salt Lake City, Utah, Rx Only. Terminated |
LSZ | None listed |
| Jan 14, 2011 | Bunnell, Inc. One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203A, Manufactured by: Bunnell Incorporated Salt Lake City, Utah, Rx Only. Terminated |
LSZ | None listed |
| May 23, 2006 | Bunnell, Inc. Life Pulse High Frequency Ventilator (HFV) Terminated |
LSZ | None listed |