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 15, 2026, FDA's public records list Skylark Device & Systems with 6 510(k) clearances. The most recent is a 510(k) clearance dated Dec 5, 2005: SKYLARK URO PROBE.
| Dec 5, 2005 | SKYLARK URO PROBEK053007 · KPI | 510(k) clearances |
| Sep 7, 2005 | BIO-STIM KITK050174 · GZJ | 510(k) clearances |
| Jun 6, 2005 | SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IRK043306 · ILY | 510(k) clearances |
| Nov 18, 2004 | SDS-4IK034005 · IPF | 510(k) clearances |
| Aug 6, 2001 | CONDUCTIVE GEL FOR ULTRASOUNDK002832 · GYB | 510(k) clearances |
| Feb 3, 2000 | SD-730 IF-SDS, PERFECT PULSE IF-SDSK992652 · 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
