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 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Clarus Medical with 10 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated May 26, 2026: Digital ClarusScope System and Digital NeuroPEN 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.
| May 26, 2026 | Digital ClarusScope System and Digital NeuroPEN SystemK252790 · HRX | 510(k) clearances |
| Apr 25, 2024 | Digital ClarusScope System; Digital NeuroPEN SystemK240535 · HRX | 510(k) clearances |
| Nov 21, 2023 | Digital ClarusScope System, Digital NeuroPEN SystemK223615 · GWG | 510(k) clearances |
| Jul 27, 2021 | Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002Class II · The sterile barrier seal may be compromised. | Device recalls |
| Mar 18, 2021 | Clarus Peel-Away Introducer SheathK200925 · GWG | 510(k) clearances |
| Apr 28, 2009 | CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-VK082038 · BTR | 510(k) clearances |
| Jun 1, 2004 | NUCLEOTOME PROBE SET, MODEL 21200K040919 · HRX | 510(k) clearances |
| May 11, 2004 | LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120K040424 · GEX | 510(k) clearances |
| Nov 5, 2002 | CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, MODEL 1160K022610 · GEX | 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
