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 15, 2026, FDA's public records list Mediana with 10 510(k) clearances and 2 device recalls. The most recent is a device recall dated May 17, 2021: AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvas….
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 17, 2021 | AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygeClass II · In some cases the equipment fails to power up and/or key or button unresponsive or not working. | Device recalls |
| Oct 9, 2020 | V20, V20a, AVSM3 SNFK200434 · DXN | 510(k) clearances |
| May 15, 2020 | DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (NIBPClass II · Failures were found in the temperature measurement function while in the predict mode. | Device recalls |
| Dec 15, 2017 | V10K170497 · DXN | 510(k) clearances |
| Feb 24, 2017 | DT-100K160358 · FLL | 510(k) clearances |
| Aug 25, 2016 | V10K152659 · DXN | 510(k) clearances |
| Nov 9, 2011 | PATIENT MONITORK112190 · MHX | 510(k) clearances |
| Nov 8, 2011 | FM20K110612 · HGM | 510(k) clearances |
| Jun 24, 2011 | F10K110630 · KNG | 510(k) clearances |
| Feb 9, 2011 | PULSE OXIMETER MODEL P10K100225 · DQA | 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
