510(k) Report

FDA applicant

Crown Delta Corp.

Yorktown Heights, NY18 decisions1976–20130 recalls

FDA records 18 decisions for Crown Delta Corp. (Yorktown Heights, NY) from 1976 to 2013: 18 510(k) clearances. Most are in product codes ELW (Material, Impression) and MNE (Orthosis, Moldable, Supportive, Skin Protective). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Crown Delta Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Crown Delta Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Crown Delta Corp.’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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Other applicant names beginning “Crown”

FDA records each applicant name separately; these may or may not be the same firm.