510(k) Report

FDA applicant

Woodbine Optical Corp.

Braintree, MA5 decisions1994–19970 recalls

FDA records 5 decisions for Woodbine Optical Corp. (Braintree, MA) from 1994 to 1997: 5 510(k) clearances. All are in product code GCJ (Laparoscope, General & Plastic Surgery). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Woodbine Optical Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Woodbine”

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