510(k) Report

FDA applicant

Migada Plant

Kiryat Shmona, IL3 decisions2005–20131 recall

FDA records 3 decisions for Migada Plant (Kiryat Shmona, IL) from 2005 to 2013: 3 510(k) clearances. Most are in product codes LHI (Set, I.V. Fluid Transfer) and FPA (Set, Administration, Intravascular). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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 Migada Plant’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007: 12013: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • LHISet, I.V. Fluid Transfer2decisions
  • FPASet, Administration, Intravascular1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K121269TBAMigada Plant · 20132cite it
  • K051669Tevadaptor Closed Drug Reconstitution and Transfer SystemMigada Plant · 20052cite it
  • K071741Tevadaptor, Closed Drug Reconstitution and Transfer SystemMigada Plant · 20072cite it

What has FDA decided for it lately?

  • K121269TBAMigada Plant · 2013
  • K071741Tevadaptor, Closed Drug Reconstitution and Transfer SystemMigada Plant · 20071 recall
  • K051669Tevadaptor Closed Drug Reconstitution and Transfer SystemMigada Plant · 20051 recall

All 3 as Migada Plant →

What has been recalled?

1 recall linked to its devices; the latest:

  • K051669TEVADAPTOR Closed Drug Reconstitution and Transfer System, a closed system used to…Dec 18, 2008

Other applicant names beginning “Migada”

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

Migada, Ltd. 16