Medical Device Manufacturer · US , Mchenry , IL

Deroyal Industries, Inc.

91 submissions · 88 cleared · Since 1984
91
Total
88
Cleared
0
Denied

Deroyal Industries, Inc. — FDA 510(k) Submissions

Deroyal Industries, Inc. has submitted 91 FDA 510(k) premarket notifications since 1984, of which 88 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Restraint, Protective, Drape, Surgical, Continuous Measurement Thermometer, Tape And Bandage, Adhesive, Electrosurgical, Cutting & Coagulation & Accessories . Use the specialty filter in the sidebar to narrow results.

91 devices
1–25 of 91
Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory
K250586 · OMP Negative Pressure Wound... · General & Plastic Surgery
Nov 2025 267d
Prospera Spectruum Negative Pressure Wound Therapy System
K230233 · OMP Negative Pressure Wound... · General & Plastic Surgery
Apr 2024 447d
DeRoyal Temperature Monitoring Probe
K200631 · FLL Continuous Measurement... · General Hospital
Dec 2020 288d
Foley Catheter with Temperature Sensor
K200757 · EYC Catheter, Upper Urinary... · Gastroenterology & Urology
Oct 2020 205d
Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French
K193027 · BZT Stethoscope, Esophageal,... · Anesthesiology
Apr 2020 155d
HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable
K200319 · FMT Warmer, Infant Radiant · General Hospital
Apr 2020 55d
Hydro-Temp Neonatal Skin Temperature Probe Cover
K191425 · FMT Warmer, Infant Radiant · General Hospital
Jan 2020 237d
Algidex Ag Silver Alginate Wound Dressing
K173072 · FRO Dressing, Wound, Drug · General & Plastic Surgery
Apr 2018 187d
DeRoyal Laprador Specimen Retrieval System
K171475 · GCJ Laparoscope, General &... · General & Plastic Surgery
Aug 2017 90d
DeRoyal Angiography Kits
K152978 · DXT Injector And Syringe,... · Cardiovascular
Mar 2016 168d
DEROYAL SPINE SPACER SYSTEM
K131292 · MAX Intervertebral Fusion... · Orthopedic
Feb 2014 273d
DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL ELECTROSURGICAL PENCIL, BUTTON STYLE WITHOUT HOLST
K132199 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Oct 2013 79d
DEROYAL NON-LOCKING BONE FIXATION SYSTEM
K090975 · HRS Plate, Fixation, Bone · Orthopedic
Apr 2010 371d
DEROYAL NON-STERILE LOCKING COMPRESSION PLATE SYSTEM
K092317 · HRS Plate, Fixation, Bone · Orthopedic
Nov 2009 90d
ULTRA HIGH PRESSURE INJECTOR LINES
K023591 · DQO Catheter, Intravascular,... · Cardiovascular
Jun 2003 236d
DEROYAL DRAPES, STERILE, NON-STERILE
K030365 · KKX Drape, Surgical · General Hospital
Apr 2003 84d
DEROYAL GOWNS, STERILE, NON-STERILE
K030364 · FYA Gown, Surgical · General Hospital
Apr 2003 83d
DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF
K991525 · DXQ Blood Pressure Cuff · Cardiovascular
Jul 1999 78d
DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER
K983750 · FMI Needle, Hypodermic,... · General Hospital
Nov 1998 38d
DEROYAL INDUSTRIES, INC. DEFOGGER
K982465 · OCT Anti Fog Solution And... · Gastroenterology & Urology
Aug 1998 27d
DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA
K974763 · HET Laparoscope, Gynecologic... · Obstetrics & Gynecology
Jul 1998 203d
DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS
K980509 · IMD Pack, Hot Or Cold,... · Physical Medicine
Feb 1998 16d
DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR
K972693 · HOZ Sponge, Ophthalmic · Ophthalmic
Sep 1997 74d
DEROYAL INDUSTRIES, INC. DISPOSABLE BIPOLAR ELECTROSURGICAL CABLE
K970993 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
May 1997 64d
PEDIATRIC LIMB HOLDER
K963466 · FMQ Restraint, Protective · General Hospital
Feb 1997 163d

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