Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in South KoreaLabelled 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 Bionet Company with 14 510(k) clearances. The most recent is a 510(k) clearance dated Dec 15, 2023: Cardio Q50, Cardio Q70.
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 |
|---|---|---|
| Dec 15, 2023 | Cardio Q50, Cardio Q70K231160 · DPS | 510(k) clearances |
| Nov 9, 2023 | Cardio P1K231150 · DPS | 510(k) clearances |
| Nov 15, 2022 | Cardio10K220535 · DPS | 510(k) clearances |
| Oct 11, 2022 | SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)K220169 · IYN | 510(k) clearances |
| Nov 15, 2013 | SPM-300K130322 · BZG | 510(k) clearances |
| Jul 16, 2012 | CARDIO 7K113306 · DPS | 510(k) clearances |
| Jun 3, 2011 | CARDIO XPK102767 · DPS | 510(k) clearances |
| Aug 26, 2009 | EKG-PLUS II SOFTWAREK090895 · LOS | 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
