510(k) Report

FDA applicant

Niti Medical Technologies, Ltd.

Netanya, IL6 decisions2004–20060 recalls

FDA records 6 decisions for Niti Medical Technologies, Ltd. (Netanya, IL) from 2004 to 2006: 6 510(k) clearances. Most are in product codes FZP (Clip, Implantable) and GDW (Staple, Implantable). Its devices cite 23 predicates, 7 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, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Niti Medical Technologies, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Niti Medical Technologies, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Niti Medical Technologies, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Niti Medical Technologies, 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

Other applicant names beginning “Niti”

FDA records each applicant name separately; these may or may not be the same firm.