FirmLabelled 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 Regulatory Insight with 4 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Sep 10, 2014: KEGEL SMART, KEGELSMART PEARL.
| Sep 10, 2014 | KEGEL SMART, KEGELSMART PEARLK140780 · HIR | 510(k) clearances |
| Apr 6, 2012 | ETHEREAK112505 · GEX | 510(k) clearances |
| Jul 1, 2008 | GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology,Class II · It was discovered that the Remote Touch Panel (RTP) of the GE Precision MPi X-ray system may not always boot up as inten | Device recalls |
| Mar 8, 2002 | EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN 600-665 AND EN 600-670 MECHANICAL WHEELCHAIRSK020094 · IOR | 510(k) clearances |
| Mar 8, 2002 | SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL WHEELCHAIRSK020100 · IOR | 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
