Medical device makerLabelled 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 13, 2026, FDA's public records list Biowave Corporation with 9 510(k) clearances. The most recent is a 510(k) clearance dated Jun 3, 2026: BioWave BioWraps.
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 |
|---|---|---|
| Jun 3, 2026 | BioWave BioWrapsK261522 · GXY | 510(k) clearances |
| Jul 8, 2021 | BioWave BioWrapsK203158 · GXY | 510(k) clearances |
| Feb 24, 2021 | BioWaveGO RXK210202 · GZJ | 510(k) clearances |
| Aug 17, 2018 | BioWaveGOK180943 · GZJ | 510(k) clearances |
| Sep 25, 2015 | BiowaveHOME Neuromodulation Pain Therapy DeviceK152437 · GZJ | 510(k) clearances |
| Feb 1, 2008 | HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICEK072123 · GZJ | 510(k) clearances |
| Aug 15, 2006 | DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEMK061166 · NHI | 510(k) clearances |
| Dec 13, 2005 | DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICEK052289 · LIH | 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
