FDA applicant
Hightech Development
FDA records 1 decision for Hightech Development (Prague, CZ) in 2018: 1 510(k) clearance. All are in product code EGJ (Device, Iontophoresis, Other Uses). 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 Hightech Development’s devices, and how often a recall has named them.
FDA decisions per year
1in 2018
2018high 1 (2018) · low 0 (2019)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Hightech Development’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) ReportOther applicant names beginning “Hightech”
FDA records each applicant name separately; these may or may not be the same firm.