Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled 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 Elucent Medical with 4 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated May 14, 2026: SmartClip Delivery Catheter (ADR-1715).
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.
| May 14, 2026 | SmartClip Delivery Catheter (ADR-1715)K260565 · EOQ | 510(k) clearances |
| Dec 20, 2024 | SmartClip Secure Soft Tissue MarkerK233639 · NEU | 510(k) clearances |
| Nov 18, 2024 | EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad Transition Cushion iClass II · There is a potential safety risk caused by physical disassociation of the back section from the bed frame of Skytron mod | Device recalls |
| Mar 22, 2019 | EnVisio Navigation SytemK183400 · NEU | 510(k) clearances |
| Jun 4, 2018 | SmartClip Soft Tissue MarkerK180640 · NEU | 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
