Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in NetherlandsLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list The Surgical Company International with 5 510(k) clearances. The most recent is a 510(k) clearance dated Nov 18, 2025: Fluido Compact System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Nov 18, 2025 | Fluido Compact SystemK252636 · LGZ | 510(k) clearances |
| Sep 4, 2025 | Fluido® AirGuard SystemK251733 · LGZ | 510(k) clearances |
| Jun 5, 2023 | Fluido Compact Blood and Fluid Warming SystemK211618 · LGZ | 510(k) clearances |
| May 26, 2017 | Mistral-Air Warming UnitK171234 · DWJ | 510(k) clearances |
| Jul 2, 2010 | MISTRAL-AIR WARMING SYSTEMK101705 · DWJ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
