FDA applicant
Pennine Medical, Ltd.
FDA records 8 decisions for Pennine Medical, Ltd. (Stoughton, MA) from 1985 to 1986: 8 510(k) clearances. Most are in product codes BSY (Catheters, Suction, Tracheobronchial) and CAE (Airway, Oropharyngeal, Anesthesiology). 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 Pennine Medical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Pennine Medical, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Pennine Medical, Ltd.’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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