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 Avita Medical with 27 510(k) clearances. The most recent is a 510(k) clearance dated Jun 11, 2026: AViTA Breast Pump.
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.
| Jun 11, 2026 | AViTA Breast PumpK250129 · HGX | 510(k) clearances |
| Feb 27, 2026 | AViTA Pulse Oximeter (SP61)K252448 · DQA | 510(k) clearances |
| Sep 3, 2025 | AViTA Arm Type Blood Pressure Monitor CuffK250765 · DXQ | 510(k) clearances |
| Feb 19, 2025 | AViTA Pulse Oximeter (SP62B)K242455 · DQA | 510(k) clearances |
| Dec 31, 2024 | Nasal Aspirator (NS 13)K241852 · BTA | 510(k) clearances |
| Oct 22, 2024 | Arm Type Blood Pressure Monitor (BPM82)K242193 · DXN | 510(k) clearances |
| May 20, 2024 | AViTA Pulse OximeterK223399 · DQA | 510(k) clearances |
| Dec 17, 2020 | Wrist Type Blood Pressure MonitorK200346 · DXN | 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
