FDA applicant

Tonometrics Holdings SA C/O Mackeen Consultants

Bethesda, MD1 decision1987–19870 recalls

FDA records 1 decision for Tonometrics Holdings SA C/O Mackeen Consultants (Bethesda, MD) in 1987: 1 510(k) clearance. All are in product code FFT (Electrode, Ph, Stomach). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Tonometrics Holdings SA C/O Mackeen Consultants’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tonometrics Holdings SA C/O Mackeen Consultants since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tonometrics Holdings SA C/O Mackeen Consultants by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tonometrics Holdings SA C/O Mackeen…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Tonometrics”

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

Tonometrics, Inc. 4

Tonometrics Holdings SA C/O Mackeen Consultants

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Tonometrics”