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Deroyal Industries, Inc.

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories8
Latest FDA decision2025-11-21
TypeNumberDevice NameCodeDateActions
510(k) K250586 Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam AccessoryOMP2025-11-21 View
510(k) K230233 Prospera Spectruum Negative Pressure Wound Therapy SystemOMP2024-04-18 View
510(k) K200631 DeRoyal Temperature Monitoring ProbeFLL2020-12-23 View
510(k) K200757 Foley Catheter with Temperature SensorEYC2020-10-15 View
510(k) K200319 HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface CableFMT2020-04-02 View
510(k) K193027 Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 FrenchBZT2020-04-02 View
510(k) K191425 Hydro-Temp Neonatal Skin Temperature Probe CoverFMT2020-01-21 View
510(k) K173072 Algidex Ag Silver Alginate Wound DressingFRO2018-04-04 View
510(k) K171475 DeRoyal Laprador Specimen Retrieval SystemGCJ2017-08-17 View
510(k) K152978 DeRoyal Angiography KitsDXT2016-03-25 View
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