510(k) K936084 ยท IMD Pack, Hot Or Cold, Disposable
OMNI WARM GEL PACKS
| Applicant | Omni Therm, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Mar 31, 1994 |
| Received | Dec 21, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K936084
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 19, 2022 | Philips North America Llc Infant Heel Warmers w/strap, Reference # 989805603201 1223 Open, Classified |
IMD | None listed |
| Jan 19, 2022 | Philips North America Llc Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T Open, Classified |
IMD | None listed |
| Jan 19, 2022 | Philips North America Llc Medichoice Infant Heel Warmer, Reference # 989805643721 1079906 Open, Classified |
IMD | None listed |
| Jan 18, 2022 | Philips North America Llc Infa-Therm Transport Mattress, Reference Number 989805616831 1015 Open, Classified |
IMD | None listed |
| Apr 4, 2016 | Philips Electronics North America Corporation evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim
A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur Terminated |
IMD | None listed |
| Dec 24, 2015 | Philips Electronics North America Corporation Cardinal Health Tiny Toes; 11470-010T Infant heel warmer Terminated |
IMD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.