Home › Device types › IMD
Pack, Hot Or Cold, Disposable
FDA product code IMD · Class 1 · Physical Medicine
627
Registered devices
4,404
Adverse events
26
Recalls
82
510(k) clearances
Devices with this code
Medi-First Cold Compress Large — Medique ProductsFirst Aid Only — Acme United CorporationHCS — Concordance Healthcare Solutions LLCMedline — MEDLINE INDUSTRIES, INC.HCS — Concordance Healthcare Solutions LLCHAWK Warming Grid — Safeguard US Operating, LLCReady-Heat — TECHTRADE, LLCASP MEDICAL — Asp Global, LLCCARDINAL HEALTH — CARDINAL HEALTH 200, LLC16PW - PG&E - Poly White — Certified Safety Manufacturing, Inc.MEDLINE — MEDLINE INDUSTRIES, INC.Halyard — O&M HALYARD, INC.HELIOS System — TACTICAL MEDICAL SOLUTIONS, LLCVpod Elite — Cool Comforts Co.Ready-Heat — TECHTRADE, LLCHalyard — OWENS & MINOR DISTRIBUTION, INC.24M - Class A Select - Metal — Certified Safety Manufacturing, Inc.Halyard — OWENS & MINOR DISTRIBUTION, INC.Halyard — OWENS & MINOR DISTRIBUTION, INC.ASP MEDICAL — Asp Global, LLCHCS — DYAD MEDICAL SOURCING, LLC36M - Marathon Petroleum LS Terminals - Metal — Certified Safety Manufacturing, Inc.Curaplex — BOUND TREE MEDICAL, LLCHCS — DYAD MEDICAL SOURCING, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-27 | Safeguard US Operating LLC | Incorrect expiration date. |
| 2024-08-27 | Safeguard US Operating LLC | Incorrect expiration date. |
| 2024-08-27 | Safeguard US Operating LLC | Incorrect expiration date. |
| 2021-11-29 | Philips North America Llc | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modifie |
| 2021-11-29 | Philips North America Llc | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modifie |
| 2021-11-29 | Philips North America Llc | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modifie |
| 2021-11-26 | Philips North America Llc | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modifie |
| 2019-07-08 | CooperSurgical, Inc. | The firm updated the IFU in April 2019 to clarify that use of the TRANSWARMER Mattress with other heat producing devices, such as an incubator, is prohibited an |
| 2019-04-26 | PF Consumer Healthcare 1 LLC | There is the potential that a HeatWrap could include cells that have a higher cell temperature than specified in lot S97473. The use of heat cell wrap with incr |
| 2019-04-26 | PF Consumer Healthcare 1 LLC | There is the potential that a HeatWrap could include cells that have a higher cell temperature than specified in lot S97473. The use of heat cell wrap with incr |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.