FDA applicant
The Ludlow Company LP
FDA records 3 decisions for The Ludlow Company LP (Chicopee, MA) from 2001 to 2002: 3 510(k) clearances. Most are in product codes FRP (Holder, Infant Position) and DRO (Pacemaker, Cardiac, External Transcutaneous…). 8 recalls are linked to its devices, 4 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided The Ludlow Company LP’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for The Ludlow Company LP since 2007.
Recalls per year
2in 2015
Class I Class II/III not classified
Planning a device like The Ludlow Company LP’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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