510(k) Report

FDA applicant

Teva Medical Ltd., Migada Plant

Kiryat Shmona, IL4 decisions2014–20180 recalls

FDA records 4 decisions for Teva Medical Ltd., Migada Plant (Kiryat Shmona, IL) from 2014 to 2018: 4 510(k) clearances. Most are in product codes ONB (Closed Antineoplastic And Hazardous Drug…) and FPA (Set, Administration, Intravascular). Its devices cite 7 predicates, 2 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 hospital panel, where it files most

How often FDA has decided Teva Medical Ltd., Migada Plant’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2014: 12015: 12017: 12018: 1
2014high 1 (2014) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Teva Medical Ltd., Migada Plant by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Teva Medical Ltd., Migada Plant’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 “Teva”

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