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 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Deroyal Industries and its 5 subsidiaries with 239 device recalls and 99 510(k) clearances. The most recent is a 510(k) clearance dated Nov 21, 2025: Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Access….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Deroyal Industries and its 5 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Nov 21, 2025 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam AccessoryK250586 · OMP | 510(k) clearances |
| Apr 18, 2024 | Prospera Spectruum Negative Pressure Wound Therapy SystemK230233 · OMP | 510(k) clearances |
| Sep 2, 2021 | DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming SetClass I · DeRoyal manufactured procedure packs containing a Smiths Medical NORMOFLO Irrigation Warming System which is recalled du | Device recalls |
| Dec 23, 2020 | DeRoyal Temperature Monitoring ProbeK200631 · FLL | 510(k) clearances |
| Oct 15, 2020 | Foley Catheter with Temperature SensorK200757 · EYC | 510(k) clearances |
| Apr 2, 2020 | HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface CableK200319 · FMT | 510(k) clearances |
| Apr 2, 2020 | Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 FrenchK193027 · BZT | 510(k) clearances |
| Feb 6, 2020 | Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of Intl-Cardiac Surgery Kit - Product Usage: This deviClass II · The sterile packaging has the potential to be compromised. | Device recalls |
| Feb 4, 2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Thyroid Pack 89-6302.14Class II · Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate cont | Device recalls |
| Feb 4, 2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Ocular Plastics Pack 89-6498.13Class II · Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate cont | Device recalls |
| Feb 4, 2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Shoulder Pack 89-4751.08Class II · Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate cont | Device recalls |
| Feb 4, 2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;Class II · Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate cont | Device recalls |
| Feb 4, 2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Cystoscopy Pack 89-6071.15Class II · Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate cont | Device recalls |
| Feb 4, 2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC General Pack 89-6015.16Class II · Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate cont | Device recalls |
| Jan 21, 2020 | Hydro-Temp Neonatal Skin Temperature Probe CoverK191425 · FMT | 510(k) clearances |
| Apr 4, 2018 | Algidex Ag Silver Alginate Wound DressingK173072 · FRO | 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
