FDA applicant

Zygotek Assoc.

London W12 8nz, GB1 decision1985–19850 recalls

FDA records 1 decision for Zygotek Assoc. (London W12 8nz, GB) in 1985: 1 510(k) clearance. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Zygotek Assoc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Zygotek Assoc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Zygotek”

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

Zygotek Systems, Inc. 1

Zygotek Assoc.

What has FDA decided for it lately?

Other applicant names beginning “Zygotek”