FDA applicant
Medispec, Ltd.
FDA records 6 decisions for Medispec, Ltd. (Germantown, MD) from 1997 to 2023: 4 510(k) clearances and 2 original PMA approvals. Most are in product codes LNS (Lithotriptor, Extracorporeal Shock-Wave…) and ISA (Massager, Therapeutic, Electric). Its devices cite 8 predicates, 1 of them its own earlier devices. 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 Medispec, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Medispec, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report