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 its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Ivy Biomedical Systems with 27 510(k) clearances. The most recent is a 510(k) clearance dated Sep 13, 2024: RT Carbon ECG Leads.
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.
| Sep 13, 2024 | RT Carbon ECG LeadsK240087 · DSA | 510(k) clearances |
| May 14, 2021 | Cardiac Trigger MonitorK202138 · DRT | 510(k) clearances |
| Mar 2, 2021 | MRI PPG Patient CableK203653 · LNH | 510(k) clearances |
| Mar 28, 2020 | MRI ECG Patient CableK192852 · LNH | 510(k) clearances |
| Mar 14, 2018 | MR Wireless Gating System, Model WGS-100K171778 · LNH | 510(k) clearances |
| May 17, 2017 | Cardiac Trigger MonitorK170828 · DRT | 510(k) clearances |
| May 27, 2016 | Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization MonitorK151781 · DRT | 510(k) clearances |
| Jul 22, 2011 | CARDIAC TRIGGER MONITORK110987 · DRT | 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
