Medical Device Manufacturer · US , Mchenry , IL

Deroyal Industries, Inc. - FDA 510(k) Cleared Devices

91 submissions · 88 cleared · Since 1984

Recent clearances: Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory, Prospera Spectruum Negative Pressure Wound Therapy System, DeRoyal Temperature Monitoring Probe

91

Total

88

Cleared

0

Denied

FDA 510(k) Regulatory Record - Deroyal Industries, Inc. General Hospital ✕

36 devices

1-12 of 36

Cleared Dec 23, 2020

DeRoyal Temperature Monitoring Probe

General Hospital · 288d

Cleared Apr 02, 2020

HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin...

General Hospital · 55d

Cleared Jan 21, 2020

Hydro-Temp Neonatal Skin Temperature Probe Cover

General Hospital · 237d

Cleared Apr 29, 2003

DEROYAL DRAPES, STERILE, NON-STERILE

General Hospital · 84d

Cleared Apr 28, 2003

DEROYAL GOWNS, STERILE, NON-STERILE

General Hospital · 83d

Cleared Nov 30, 1998

DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER

General Hospital · 38d

Cleared Feb 13, 1997

PEDIATRIC LIMB HOLDER

General Hospital · 163d

Cleared Jan 22, 1997

RESTRICTIVE LIMB HOLDER

General Hospital · 141d

Cleared Jan 22, 1997

TUXEDO VEST RESTRAINT

General Hospital · 141d

Cleared Jan 22, 1997

DISPOSABLE LIMB HOLDER

General Hospital · 141d

Cleared Jan 03, 1997

General Hospital · 122d

Cleared Dec 19, 1996

General Hospital · 107d