FDA applicant
Teknomed, Inc.
FDA records 7 decisions for Teknomed, Inc. (Danvers, MA) from 1979 to 1993: 7 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and FFK (Lithotriptor, Electro-Hydraulic). 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 Teknomed, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Teknomed, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Teknomed, Inc.’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