FDA applicant
Stihler Electronic GmbH
FDA records 7 decisions for Stihler Electronic GmbH (Sound Beach, NY) from 1999 to 2026: 7 510(k) clearances. Most are in product codes BSB (Warmer, Blood, Non-Electromagnetic Radiation) and DWJ (System, Thermal Regulating). Its devices cite 6 predicates, 2 of them its own earlier devices. 3 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Stihler Electronic GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
3in 2018
Class I Class II/III not classified
Planning a device like Stihler Electronic GmbH’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 “Stihler”
FDA records each applicant name separately; these may or may not be the same firm.