510(k) Report

FDA applicant

Tursiop Technologies, LLC

Cleveland, OH2 decisions2008–20110 recalls

FDA records 2 decisions for Tursiop Technologies, LLC (Cleveland, OH) from 2008 to 2011: 2 510(k) clearances. All are in product code MOS (Coil, Magnetic Resonance, Specialty). Its devices cite 2 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, radiology panel, where it files most

How often FDA has decided Tursiop Technologies, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2008: 12011: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Tursiop Technologies, LLC by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tursiop Technologies, LLC’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

Which product codes does it file in?

  • MOSCoil, Magnetic Resonance, Specialty2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K083434TT1 General Purpose CoilTursiop Technologies, LLC · 20081cites it

What has FDA decided for it lately?

  • K113280Carotid Coil GE 1.5TTursiop Technologies, LLC · 2011
  • K083434TT1 General Purpose CoilTursiop Technologies, LLC · 2008

All 2 as Tursiop Technologies, LLC →