FDA applicant

Sylvan Medical Fiberoptics

North Huntingdon, PA1 decision1992–19920 recalls

FDA records 1 decision for Sylvan Medical Fiberoptics (North Huntingdon, PA) in 1992: 1 510(k) clearance. All are in product code EBA (Light, Surgical Headlight). 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 Sylvan Medical Fiberoptics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sylvan Medical Fiberoptics since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sylvan Medical Fiberoptics’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 “Sylvan”

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

Sylvan Corp. 1

Sylvan Medical Fiberoptics

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Sylvan”