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 13, 2026, FDA's public records list IntroMedic Co., Ltd. with 11 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated May 8, 2026: MiroCam® Capsule Endoscope System.
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 |
|---|---|---|
| May 8, 2026 | MiroCam® Capsule Endoscope SystemK252617 · NEZ | 510(k) clearances |
| Nov 8, 2018 | MiroCam Capsule Endoscope SystemK180732 · NEZ | 510(k) clearances |
| Jan 30, 2018 | MiroCam Capsule Endoscope SystemK170438 · NEZ | 510(k) clearances |
| Feb 15, 2017 | Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is intended for visualization of the smallClass II · When a user switches on MR1100 Receiver, even though the battery was fully charged, the LED was displayed as orange colo | Device recalls |
| Mar 17, 2015 | MiroCam Capsule Endoscope SystemK143663 · NEZ | 510(k) clearances |
| Jul 9, 2014 | MIROCAM CAPSULE ENDOSCOPE SYSTEMK134005 · NEZ | 510(k) clearances |
| Jun 30, 2014 | MIROCAM CAPSULE ENDOSCOPE SYSTEMK140751 · NEZ | 510(k) clearances |
| Jun 21, 2013 | E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEMK131131 · EOX | 510(k) clearances |
| May 20, 2013 | MIROCAM CAPSULE ENDOSCOPE SYSTEMK123428 · NEZ | 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
