FDA applicant
Burron Medical, Inc.
FDA records 9 decisions for Burron Medical, Inc. (Bethlehem, PA) from 1988 to 1991: 9 510(k) clearances. Most are in product codes FRN (Pump, Infusion) and DRS (Transducer, Blood-Pressure, Extravascular). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Burron Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Burron Medical, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Burron Medical, 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 “Burron”
FDA records each applicant name separately; these may or may not be the same firm.