Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled 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 International Biomedical with 17 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Oct 7, 2022: Infant Heel WarmerTM; Heel Snuggler®.
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.
| Oct 7, 2022 | Infant Heel WarmerTM; Heel Snuggler®K221154 · MPO | 510(k) clearances |
| Oct 6, 2022 | InfaTherm Disposable Infant Warming MattressK221653 · IMD | 510(k) clearances |
| Jul 15, 2022 | NxtGen Infant Transport IncubatorK220742 · FPL | 510(k) clearances |
| Mar 10, 2020 | AeroNOx 2.0 Nitric Oxide Titration & Monitoring SystemK193481 · MRN | 510(k) clearances |
| Jan 18, 2019 | Puffin Lite Infant Resuscitation SystemK182956 · BTL | 510(k) clearances |
| Aug 17, 2018 | NuBorne Infant WarmerK173516 · FMT | 510(k) clearances |
| Jun 14, 2016 | Airborne Phototherapy LightK160238 · LBI | 510(k) clearances |
| May 28, 2014 | LIFEBORNE INFANT RESUSCITATORK140707 · BTL | 510(k) clearances |
| May 24, 2013 | VIA Medical Collection Bag; The collection bag is an accessory waste bag used in conjunction with the sterile LVM blood gas sensor with theClass II · International Biomedical has received reports of interference between the collection bag and the extension set connector | Device recalls |
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
