Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in GermanyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list SICAT with 9 510(k) clearances and 1 device recall. The most recent is a device recall dated Jul 15, 2020: SICAT IMPLANT V2.0.
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.
| Date | Record | Source |
|---|---|---|
| Jul 15, 2020 | SICAT IMPLANT V2.0Class II · A dentist found implant positions are not correctly exported from the implant planning software SICAT IMPLANT V2.0 - for | Device recalls |
| Dec 4, 2019 | SICAT Implant V2.0K192348 · LLZ | 510(k) clearances |
| Mar 12, 2018 | SICAT EndoK180262 · LLZ | 510(k) clearances |
| Mar 31, 2016 | SICAT OPTISLEEPK153291 · LRK | 510(k) clearances |
| Oct 2, 2015 | SICAT OPTIMOTIONK143655 · MQC | 510(k) clearances |
| Feb 25, 2014 | SICAT FUNCTIONK133320 · LLZ | 510(k) clearances |
| May 20, 2011 | SICAT IMPLANT V1.2K103723 · LLZ | 510(k) clearances |
| Dec 17, 2009 | GALILEOS IMPLANT, VERSION 1.7K093090 · LLZ | 510(k) clearances |
| Feb 5, 2009 | SICAT IMPLANTK090119 · LLZ | 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
