FDA applicant
Stephenson Industries, Inc.
FDA records 4 decisions for Stephenson Industries, Inc. (Farmingdale, NJ) from 1985 to 1997: 4 510(k) clearances. Most are in product codes KPJ (Chamber, Oxygen, Topical, Extremity) and BTL (Ventilator, Emergency, Powered (Resuscitator)). 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 Stephenson Industries, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Stephenson Industries, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Stephenson Industries, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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