FDA applicant
Bunnell, Inc.
FDA records 1 decision for Bunnell, Inc. (Salt Lake City) in 1988: 1 original PMA approval. All are in product code LSZ (Ventilator, High Frequency). 4 recalls are linked to its devices, 1 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Bunnell, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Bunnell, Inc. since 2007.
Recalls per year
1in 2012
Class I Class II/III not classified
Planning a device like Bunnell, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Bunnell”
FDA records each applicant name separately; these may or may not be the same firm.