FDA applicant
Pennwalt Corp.
FDA records 6 decisions for Pennwalt Corp. (Mchenry, IL) from 1978 to 1983: 6 510(k) clearances. Most are in product codes EAP (Unit, X-Ray, Intraoral) and EJK (Liner, Cavity, Calcium Hydroxide). 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 Pennwalt Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Pennwalt Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Pennwalt Corp.’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) Report