510(k) Report

FDA applicant

Tangent Medical Technologies, Inc.

Ann Arbor, MI2 decisions2012–20160 recalls

FDA records 2 decisions for Tangent Medical Technologies, Inc. (Ann Arbor, MI) from 2012 to 2016: 2 510(k) clearances. All are in product code FOZ (Catheter, Intravascular, Therapeutic…). Its devices cite 4 predicates, 1 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 Tangent Medical Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2012: 12016: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Tangent Medical Technologies, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tangent Medical Technologies, Inc.’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 “Tangent”

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