Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in South KoreaLabelled 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 14, 2026, FDA's public records list Sooil Development Co., Ltd. with 4 510(k) clearances and 2 warning letters. The most recent is a warning letter dated Feb 21, 2023: Warning letter: Medical Devices.
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.
| Feb 21, 2023 | Warning letter: Medical DevicesCDRH | Warning letters |
| Apr 16, 2020 | Warning letter: CAPA, MDR reporting, Design controlsCDRH | Warning letters |
| Sep 4, 2007 | DANA 3CC SYRINGE INSULIN RESERVOIRK071418 · MRZ | 510(k) clearances |
| Feb 2, 2007 | DANA DIABECARE IISK063126 · LZG | 510(k) clearances |
| Aug 2, 2002 | DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETSK022317 · LZG | 510(k) clearances |
| Aug 14, 2000 | DANA DIABECAREK001604 · LZG | 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
