FDA applicant
Randwal Instrument Co., Inc.
FDA records 6 decisions for Randwal Instrument Co., Inc. (Southbridge, MA) from 1983 to 1988: 6 510(k) clearances. Most are in product codes HLJ (Ophthalmoscope, Battery-Powered) and HPJ (Instrument, Visual Field, Laser). 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 Randwal Instrument Co., Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Randwal Instrument Co., Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Randwal Instrument Co., 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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