FDA 510(k) Applications Submitted by DeRoyal Industries, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K030364 02/04/2003 DEROYAL GOWNS, STERILE, NON-STERILE DEROYAL INDUSTRIES, INC.
K030365 02/04/2003 DEROYAL DRAPES, STERILE, NON-STERILE DEROYAL INDUSTRIES, INC.
K980509 02/10/1998 DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS DEROYAL INDUSTRIES, INC.
K961647 04/30/1996 DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL DEROYAL INDUSTRIES, INC.
K972693 07/18/1997 DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR DEROYAL INDUSTRIES, INC.
K963469 09/03/1996 MITTENS DEROYAL INDUSTRIES, INC.
K963470 09/03/1996 CRISS-CROSS VEST RESTRAINT DEROYAL INDUSTRIES, INC.
K963471 09/03/1996 SUPER SECURITY RESTRAINT DEROYAL INDUSTRIES, INC.
K963467 09/03/1996 ROLL BELTS DEROYAL INDUSTRIES, INC.
K963472 09/03/1996 PEDIATRIC VEST RESTRAINT DEROYAL INDUSTRIES, INC.
K963473 09/03/1996 REUSABLE LIMB HOLDER DEROYAL INDUSTRIES, INC.
K963474 09/03/1996 TUXEDO VEST RESTRAINT DEROYAL INDUSTRIES, INC.
K963475 09/03/1996 PONCHO VEST RESTRAINT DEROYAL INDUSTRIES, INC.
K963476 09/03/1996 DISPOSABLE LIMB HOLDER DEROYAL INDUSTRIES, INC.
K963478 09/03/1996 SLEEVED/SLEEVELESS VEST RESTRAINT DEROYAL INDUSTRIES, INC.
K963479 09/03/1996 WHEELCHAIR BELT DEROYAL INDUSTRIES, INC.
K963480 09/03/1996 MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER DEROYAL INDUSTRIES, INC.
K963463 09/03/1996 STRAIT JACKET DEROYAL INDUSTRIES, INC.
K963464 09/03/1996 RESTRAINT NET DEROYAL INDUSTRIES, INC.
K963465 09/03/1996 PELVIC HOLDER DEROYAL INDUSTRIES, INC.
K963466 09/03/1996 PEDIATRIC LIMB HOLDER DEROYAL INDUSTRIES, INC.
K963477 09/03/1996 PEDIATRIC MITTENS DEROYAL INDUSTRIES, INC.
K963468 09/03/1996 RESTRICTIVE LIMB HOLDER DEROYAL INDUSTRIES, INC.
K983750 10/23/1998 DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER DEROYAL INDUSTRIES, INC.
K974763 12/19/1997 DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA DEROYAL INDUSTRIES, INC.
K132199 07/16/2013 DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL ELECTROSURGICAL PENCIL, BUTTON STYLE WITHOUT HOLST DEROYAL INDUSTRIES, INC.
K152978 10/09/2015 DeRoyal Angiography Kits DEROYAL INDUSTRIES, INC.
K090975 04/06/2009 DEROYAL NON-LOCKING BONE FIXATION SYSTEM DEROYAL INDUSTRIES, INC.
K092317 08/04/2009 DEROYAL NON-STERILE LOCKING COMPRESSION PLATE SYSTEM DEROYAL INDUSTRIES, INC.
K023591 10/25/2002 ULTRA HIGH PRESSURE INJECTOR LINES DEROYAL INDUSTRIES, INC.
K131292 05/06/2013 DEROYAL SPINE SPACER SYSTEM DEROYAL INDUSTRIES, INC.
K991525 05/03/1999 DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF DEROYAL INDUSTRIES, INC.
K982465 07/15/1998 DEROYAL INDUSTRIES, INC. DEFOGGER DEROYAL INDUSTRIES, INC.
K970993 03/19/1997 DEROYAL INDUSTRIES, INC. DISPOSABLE BIPOLAR ELECTROSURGICAL CABLE DEROYAL INDUSTRIES, INC.
K230233 01/27/2023 Prospera Spectruum Negative Pressure Wound Therapy System DeRoyal Industries, Inc.
K200319 02/07/2020 HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable DeRoyal Industries, Inc.
K200631 03/10/2020 DeRoyal Temperature Monitoring Probe DeRoyal Industries, Inc.
K200757 03/24/2020 Foley Catheter with Temperature Sensor DeRoyal Industries, Inc.
K171475 05/19/2017 DeRoyal Laprador Specimen Retrieval System DeRoyal Industries, Inc.
K191425 05/29/2019 Hydro-Temp Neonatal Skin Temperature Probe Cover DeRoyal Industries, Inc.
K173072 09/29/2017 Algidex Ag Silver Alginate Wound Dressing DeRoyal Industries, Inc.
K193027 10/30/2019 Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French DeRoyal Industries, Inc.


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