FirmLabelled 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 Burke with 7 510(k) clearances. The most recent is a 510(k) clearance dated Aug 1, 2006: FUSION.
| Date | Record | Source |
|---|---|---|
| Aug 1, 2006 | FUSIONK061912 · INI | 510(k) clearances |
| Dec 24, 2002 | SCOUT BOSSK023961 · ITI | 510(k) clearances |
| Aug 31, 1998 | SCOUTK982158 · ITI | 510(k) clearances |
| Jul 17, 1997 | PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)K965123 · INI | 510(k) clearances |
| Jul 19, 1991 | CONCEPT MODEL 5200 THERMAL THERAPY SYSTEMK911943 · ILO | 510(k) clearances |
| Jun 22, 1989 | COLD/HOT FLUID RADIATION PAD NEUTECHK893706 · ILO | 510(k) clearances |
| Jan 30, 1984 | PACESAVER & SCOUTK834506 · INI | 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
