Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in JapanLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Atom Medical Corporation with 15 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated May 23, 2013: ATOM TRANSCAPSULE V-707.
| May 23, 2013 | ATOM TRANSCAPSULE V-707K123937 · FPL | 510(k) clearances |
| Jul 6, 2012 | SUNFLOWER WARNERK120937 · FMT | 510(k) clearances |
| May 1, 2012 | Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator Class II · There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mod | Device recalls |
| Apr 12, 2012 | BILI-THERAPY PAD TYPEK111547 · LBI | 510(k) clearances |
| Apr 20, 2011 | RESUSCITATION UNIT 105K103317 · BZR | 510(k) clearances |
| Apr 6, 2011 | RESUSCI FLOW; RESUSCI FLOW 104K102542 · BTL | 510(k) clearances |
| Mar 29, 2011 | BILI-THERAPY SPOT TYPEK103828 · LBI | 510(k) clearances |
| Jan 21, 2011 | INFA WARMER IK102227 · FMT | 510(k) clearances |
| Jan 4, 2011 | DUAL INCU IK102226 · FMZ | 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
