FDA Registration Active 🇺🇸 United States

DEROYAL INDUSTRIES, INC.

Reg #: 1043214 · FEI: 1043214 · Expires 2026
Products
357
Proprietary Names
395
Establishment Types
4
Classifications
357

Registration Details

Registration Name
DEROYAL INDUSTRIES, INC.
Registration Number
1043214
FEI Number
1043214
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
200 DEBUSK LN.
City
POWELL
State
TN
ZIP
37849
Country
US

Regulatory Submissions

510(k) Number
K952775

Owner / Operator

Firm Name
DEROYAL INDUSTRIES, INC.
Operator Number
1044833
Address
200 DEBUSK LN., --
City
Powell
State
TN
Postal Code
37849
Country
US
Correspondent
Elizabeth Reed

Products

Device Name Product Code
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic MGQ
Laparoscopy Kit FDE
Restraint, Wheelchair, Non-Protective KID
Dressing, Wound, Drug FRO
Injector And Syringe, Angiographic DXT
Electrosurgical, Cutting & Coagulation & Accessories GEI
Suture Removal Kit MCZ
Guide, Needle, Surgical GDF
Syringe, Piston FMF
Mask, Oxygen BYG
Arthroscope HRX
Drape, Surgical, Antimicrobial KKX
Orotracheal Intubation Guide Kit OGK
Lubricant, Patient KMJ
Staple, Removable (Skin) GDT
Set, Administration, Intravascular FPA
Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
Catheter, Intravascular, Diagnostic DQO
Laparoscope, General & Plastic Surgery GCJ
Bag, Intestine KGY
Orthosis, Truncal/Orthosis, Limb MRI
Tube, Levine FRQ
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
Intervertebral Fusion Device With Bone Graft, Cervical ODP
Airway, Oropharyngeal, Anesthesiology CAE
Pap Smear Kit OHL
Tube, Double Lumen For Intestinal Decompression And/Or Intubation FEG
Connector, Catheter GCD
Clamp HXD
Mask, Surgical FXX
Accessory Equipment, Cardiopulmonary Bypass KRI
Crutch IPR
Orthosis, Limb Brace IQI
Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
Skin Prep Tray OJU
System, X-Ray, Angiographic IZI
Apparatus, Electrosurgical HAM
Clip, Implantable FZP
Saline, Vascular Access Flush NGT
Cushion, Wheelchair IMP
Catheter, Urological KOD
Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
Transducer, Blood-Pressure, Extravascular DRS
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
Light, Surgical, Accessories FTA
Wire, Guide, Catheter DQX
Condom HIS
Introducer, Catheter DYB
Bed, Ac-Powered Adjustable Hospital FNL
Container, Empty, For Collection & Processing Of Blood & Blood Components KSR
Sling, Arm ILI
Body Fluids Barrier Kit OKH
Gown, Surgical FYA
Tubing, Noninvasive GAZ
Container, I.V. KPE
Cover, Shoe, Operating-Room FXP
Operating Room Accessories Table Tray FWZ
Absorber, Saliva, Paper KHR
Catheter, Straight EZD
Bag, Reservoir BTC
Aid, Transfer IKX
Dressing, Wound, Occlusive NAD
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) FCM
Collector, Urine, (And Accessories) For Indwelling Catheter KNX
Gauze/Sponge, Internal, X-Ray Detectable GDY
Catheter, Continuous Irrigation GBQ
Clamp, Vascular DXC
Joint, Shoulder, External Limb Component IQQ
Appliance, Fixation, Spinal Intervertebral Body KWQ
Sponge, Ophthalmic HOZ
Pad, Menstrual, Unscented HHD
Marker, Skin FZZ
Catheter, Upper Urinary Tract EYC
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene DXZ
Hemostat HRQ
Splint, Hand, And Components ILH
Continuous Measurement Thermometer FLL
I.V. Start Kit LRS
Catheter, Conduction, Anesthetic BSO
Handle, Scalpel GDZ
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) KNF
Wrap, Sterilization FRG
Needle, Suturing, Disposable GAB
Caliper, Ophthalmic HOE
Container, Specimen, Sterile FMH
Catheter, Urethral GBM
Staple, Implantable GDW
Punch, Surgical LRY
Pump, Infusion, Pca MEA
System, X-Ray, Fluoroscopic, Image-Intensified JAA
Coagulator, Laparoscopic, Unipolar (And Accessories) HFG
Needle, Hypodermic, Single Lumen FMI
Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
Lamp, Surgical FTD
Dressing, Wound, Hydrophilic NAC
Spinal Vertebral Body Replacement Device MQP
Culture Media, Non-Selective And Non-Differential JSG
Toothbrush, Manual EFW
Negative Pressure Wound Therapy Powered Suction Pump OMP
Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
Speculum, Vaginal, Metal HDF
Accessories, Catheter KGZ
Orthosis, Lumbo-Sacral IPY
Suture, Nonabsorbable, Synthetic, Polyamide GAR
Bedding, Disposable, Medical KME
Vinyl Patient Examination Glove LYZ
Surgeon'S Gloves KGO
Counter, Sponge, Surgical LWH
Tourniquet Kit OJS
Clean-Up Kit PWU
Component, Traction, Non-Invasive KQZ
Joint, Ankle, External Brace ITW
Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
Container, Specimen, Non-Sterile NNI
Minor Surgical Procedures Tray PYB
General Surgery Tray LRO
Electrode, Pacemaker, Temporary LDF
Cover, Barrier, Protective MMP
Suture, Nonabsorbable, Silk GAP
Dressing Change Tray OXQ
Neurosurgical Paddie HBA
Exerciser, Powered BXB
Lavage, Jet FQH
Suture, Nonabsorbable, Synthetic, Polyethylene GAT
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile GAQ
Device, Fixation, Tracheal Tube CBH
Cannula, Injection FGY
Tubing, Pump, Cardiopulmonary Bypass DWE
System, Thermal Regulating DWJ
Device, Intravascular Catheter Securement KMK
Gauze/Sponge, Internal EFQ
Dissector, Surgical, General & Plastic Surgery GDI
Adaptor, Grooming ILW
Speculum, Vaginal, Nonmetal HIB
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
Clip, Removable (Skin) FZQ
Apparatus, Exhaust, Surgical FYD
Cardiovascular Surgical Instruments Tray OFA
Catheter, Cholangiography GBZ
Urinary Drainage Collection Kit, For Indwelling Catheter FCN
Tape And Bandage, Adhesive KGX
Warmer, Infant Radiant FMT
Incubator, Neonatal FMZ
Sheet, Burn FPY
Central Venous Catheter Dressing Change Kit PEZ
Anesthesia Conduction Kit CAZ
Table, Cystometric, Electric MMZ
Medical Glove, Specialty LZC
Polymer Patient Examination Glove LZA
Blade, Saw, Surgical, Cardiovascular DWH
Cutter, Surgical FZT
Fiber, Medical, Absorbent FRL
Circumcision Tray OHG
Trap, Sterile Specimen BYZ
Tubes, Vacuum Sample, With Anticoagulant GIM
Hook, Tracheal KCH
Blade, Scalpel GES
System, Irrigation, Urological LJH
Dressing, Compression MHW
Gown, Isolation, Surgical FYC
Sound, Uterine HHM
Insufflator, Laparoscopic HIF
Sigmoidoscope And Accessories, Flexible/Rigid FAM
Suture Kit OVN
Insoles, Medical KYS
Instruments, Surgical, Cardiovascular DWS
Bedpan FOB
Razor, Surgical LWK
Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
Blade, Saw, General & Plastic Surgery, Surgical GFA
Stethoscope, Esophageal, With Electrical Conductors BZT
Drape, Patient, Ophthalmic HMT
Accessories, Traction ILZ
Laparoscope, Gynecologic (And Accessories) HET
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
Joint, Knee, External Brace ITQ
Restraint, Protective FMQ
Suture, Nonabsorbable GAO
Support, Patient Position CCX
Burn Kit Without Drug OJJ
Electrode, Cutaneous GXY
Retractor GAD
Hemostat, Surgical EMD
Labor And Delivery Kit MLS
Stopcock, I.V. Set FMG
Orthopedic Manual Surgical Instrument LXH
Pelvic Exam Kit MLT
Accessory, Surgical Apparel LYU
Specula, Ophthalmic HNC
Suture, Surgical, Absorbable, Polydioxanone NEW
Tubing, Fluid Delivery FPK
Cover, Limb IPM
Cannula, Surgical, General & Plastic Surgery GEA
Carrier, Ligature GEJ
Scalpel, One-Piece GDX
Thoracolumbosacral Pedicle Screw System NKB
Orthosis, Spinal Pedicle Fixation MNI
Orthosis, Spondylolisthesis Spinal Fixation MNH
General Purpose Dental Tray OFX
Suture, Nonabsorbable, Synthetic, Polypropylene GAW
Splint, Extremity, Inflatable, External FZF
Exerciser, Non-Measuring ION
Bandage, Liquid, Skin Protectant NEC
Table, Cysto, Non-Electrical EYH
Anesthesia Breathing Circuit Kit (Adult & Pediatric) OFP
Support, Arm IOY
Applier, Surgical, Clip GDO
Catheter, Retention Type, Balloon EZL
Catheter, Urological (Antimicrobial) And Accessories MJC
Insufflator, Endoscopic Vessel Harvesting OSV
Splint, Abduction, Congenital Hip Dislocation IOZ
Electrode, Electrocardiograph DRX
Monitor, Bed Patient KMI
Apparatus, Suction, Ward Use, Portable, Ac-Powered JCX
Ear, Nose, And Throat Surgical Tray OGR
Pack, Hot Or Cold, Disposable IMD
Gynecological Laparoscopic Kit OHD
Suture, Absorbable, Synthetic GAN
Orthosis, Rib Fracture, Soft IPX
Blood Pressure Cuff DXQ
Garment, Protective, For Incontinence EYQ
Slides, Microscope KEW
Scissors, General, Surgical LRW
Syringe, Irrigating (Non Dental) KYZ
Bandage, Cast ITG
Wound Dressing With Animal-Derived Material(S) KGN
Aspiration Tray OJT
Tubing/Tubing With Filter, Insufflation, Laparoscopic NKC
Instrument, Ligature Passing And Knot Tying HCF
Shoe, Cast IPG
Protector, Skin Pressure FMP
Cesarean Section Tray OHM
Transducer, Pressure, Catheter Tip DXO
Fentanyl And Other Opioid Protection Glove QDO
Orthosis, Cervical-Thoracic, Rigid IQF
Bag, Ice KYR
Device, Occlusion, Umbilical FOD
Securement Wound Dressing For Reduction Of Infection SEL
Monitor, Line Isolation DRI
Clip, Vascular DSS
Electrocautery, Gynecologic (And Accessories) HGI
Depressor, Tongue, Non-Surgical FMA
Tubing, Pressure And Accessories BYX
Splint, Clavicle IQJ
Knife, Ophthalmic HNN
Anti Fog Solution And Accessories, Endoscopy OCT
Scissors, Medical, Disposable JOK
Component, External, Limb, Ankle/Foot ISH
Bandage, Liquid KMF
Catheter, Irrigation GBX
Splint, Traction HSP
Container, Liquid Medication, Graduated KYW
Cane IPS
Trephine, Manual, Ophthalmic HRH
Strip, Temperature, Forehead, Liquid Crystal KPD
Halter, Head, Traction HSS
Catheters, Suction, Tracheobronchial BSY
Forceps, Ophthalmic HNR
Dilator, Vessel, For Percutaneous Catheterization DRE
Hood, Surgical FXY
System, Imaging, Pulsed Echo, Ultrasonic IYO
Catheter And Tip, Suction JOL
Solvent, Adhesive Tape KOX
Holder, Needle, Gastroenterologic FHQ
Applicator, Absorbent Tipped, Non-Sterile KXF
Device, Specimen Collection LIO
Orthosis, Corrective Shoe KNP
Suture, Absorbable, Natural GAL
Tray, Surgical, Instrument FSM
Cannula, Ophthalmic HMX
Pad, Alcohol, Device Disinfectant LKB
Bandage, Elastic FQM
Surgical Table Cushion LWG
Snare, Surgical GAE
Forceps HTD
Sampler, Amniotic Fluid (Amniocentesis Tray) HIO
Tray, Surgical LRP
Pack, Hot Or Cold, Water Circulating ILO
Basin, Emesis FNY
Orthosis, Cervical IQK
Clamp, Surgical, General & Plastic Surgery GDJ
Hook, Surgical, General & Plastic Surgery GDG
Tape, Measuring, Rulers And Calipers FTY
Holder, Needle; Orthopedic HXK
Laryngoscope, Endoscope GCI
Stocking, Elastic ILG
Wax, Bone MTJ
Pneumoperitoneum Needle FHO
Wound Dressing Kit MCY
Adaptor, Dressing ILD
Probe HXB
Device, Transfer, Patient, Manual FMR
Nerve Block Tray OGJ
Pad, Neonatal Eye FOK
Angiography/Angioplasty Kit OEQ
Instrument, Cranioplasty Material Forming HBX
Accessories, Cleaning Brushes, For Endoscope MNL
Dilator, Urethral KOE
Syringe, Balloon Inflation MAV
Eye Tray OJK
Unit, Filter, Membrane JRL
Applicator, Absorbent Tipped, Sterile KXG
Tourniquet, Pneumatic KCY
Lift, Patient, Non-Ac-Powered FSA
Forceps, General & Plastic Surgery GEN
Bottle, Collection, Vacuum KDQ
Balloon, Epistaxis EMX
Stapler, Skin QQS
Blood And Urine Collection Kit (Excludes Hiv Testing) OIB
Dilator, Vessel, Surgical DWP
Tube, Aspirating, Flexible, Connecting BYY
Stocking, Medical Support (For General Medical Purposes) FQL
Agent, Absorbable Hemostatic, Non-Collagen Based LMG
Dispenser, Liquid Medication KYX
Clip, Scalp HBO
Mask, Gas, Anesthetic BSJ
Tissue Adhesive For The Topical Approximation Of Skin MPN
Tourniquet, Nonpneumatic GAX
Needle, Catheter GCB
Catheter, Peritoneal GBW
Gauze / Sponge,Nonresorbable For External Use NAB
Unit, Suction Operatory EBR
Cannula, Manipulator/Injector, Uterine LKF
Cystotome HNY
Binder, Abdominal FSD
Pack, Hot Or Cold, Reusable IME
Pad, Eye HMP
Drape, Surgical, Exempt PUI
Amniotome HGE
Pump, Portable, Aspiration (Manual Or Powered) BTA
Catheter, Coude EZC
Camera, Surgical And Accessories KQM
Filter, Bacterial, Breathing-Circuit CAH
Joint, Elbow, External Limb Component, Mechanical IRD
Laparoscopic Accessories, Gynecologic NWV
Tubes, Gastrointestinal (And Accessories) KNT
Catheter, Angioplasty, Peripheral, Transluminal LIT
Syringe, Periodontic, Endodontic, Irrigating EIC
Cotton, Roll EFN
Catheter, Umbilical Artery FOS
Needle, Aspiration And Injection, Disposable GAA
Hysterectomy Kit OJF
Label Or Tag, Sterile LYV
Cardiovascular Procedure Kit OEZ
Walker, Mechanical ITJ
Instrument, Surgical, Disposable KDC
Apparatus, Traction, Non-Powered HST
Kit, Surgical Instrument, Disposable KDD
Container, Specimen Mailer And Storage, Sterile KDT
Truss, Umbilical EXM
Bag, Urine Collection, Leg, For External Use, Non-Sterile NNW
Transducer, Ultrasonic, Diagnostic ITX
Instrument, Manual, Surgical, General Use MDM
Jelly, Lubricating, For Transurethral Surgical Instrument FHX
Infant Heel Warmer (Chemical Heat Pack) MPO
Tube, Feeding FPD

Proprietary Names

Dressing, Wound and Burn, Hydrogel W/Drug and/or Biologic - DeRoyal Multidex Laparoscopy Kit - DeRoyal Restraint, Wheelchair, Non-Protective - DeRoyal Dressing, Wound, Drug - DeRoyal Injector and Syringe Angiographic - DeRoyal Electrosurgical Cutting & Coagulation Accessories - DeRoyal Suture Removal Kit - DeRoyal Guide, Needle, Surgical - DeRoyal Syringe, Piston - DeRoyal Mask, Oxygen - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal HRX Arthroscope GEI Electrosurgical, Cutting & coagulation & Accessories - DeRoyal Drape, Surgical - DeRoyal Orotracheal Intubation Guide Kit - DeRoyal Lubricant, Patient - DeRoyal Staple, Removeable (Skin) - DeRoyal Set, Administration, Intravascular - DeRoyal Tubes, Vials, Systems, Serum Separators, Blood Collection - DeRoyal Catheter, Intravascular, Diagnostic - DeRoyal Laparoscope, General & Plastic Surgery - DeRoyal Bag, Intestine - DeRoyal Orthosis, Truncal/Orthosis, Limb - DeRoyal Tube, Levine - DeRoyal Catheter, Cannula and Tubing, Vascular, Cardiopulmonary By Pass - DeRoyal Intervertebral Fusion Device with Bone Graft, Cervical - DeRoyal Airway, Oropharyngeal, Anesthesiology - DeRoyal Pap Smear Kit - DeRoyal Tube, Double Lumen for Intestinal Decompression and/or Intubation - DeRoyal Connector, Catheter - DeRoyal CLAMP - DeRoyal Mask, Surgical - DeRoyal Accessory Equipment, Cardiopulmonary Bypass - DeRoyal Crutch - DeRoyal Orthosis, Limb Brace - DeRoyal Yankauer - DeRoyal Skin Prep Tray (Kit)- DeRoyal System, X-Ray, Angiographic - DeRoyal Electrosurgical, cutting & coagulation & accessories - DeRoyal Clip, Implantable - DeRoyal Saline, Vascular Access Flush - DeRoyal Cushion, Wheelchair - DeRoyal Catheter, Urological - DeRoyal Suture, Absorbable, Synthetic, Polyglycolic Acid - DeRoyal Transducer, Blood-Pressure, Extravascular - DeRoyal Apparatus, Suction, Operating-Room, Wall Vacuum Powered - DeRoyal Set, administration, intravascular - DeRoyal Catheter, Intravascular, Therapeutic, Short-term less than 30 days - DeRoyal Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase - DeRoyal Injector and Syringe, Angiographic - DeRoyal Light, Surgical, Accessories - DeRoyal Wire, Guide, Catheter - DeRoyal Condom - DeRoyal Introducer, Catheter - DeRoyal Bed, Ac-Powered Adjustable Hospital - DeRoyal Container, Empty, for Collection & Processing of Blood & Blood Components - DeRoyal Arthroscope - DeRoyal Sling, Arm - DeRoyal Body Fluid Barrier Kit - DeRoyal Gown, Surgical - DeRoyal Tubing, Noninvasive - DeRoyal Container, I. V. - DeRoyal Cover, Shoe, Operating-room - DeRoyal Accessories, Operating-Room, Table (Kit) - DeRoyal Absorber, Saliva, Paper - DeRoyal Catheter, Straight - DeRoyal Bag, Reservoir - DeRoyal Aid, Transfer - DeRoyal Dressing, Wound, Occlusive - DeRoyal Collector, Urine, (and Accessories) for Indwell Cath/ Tray, Catheteriz, Sterile Urethral, w/wo Catheter (kit)- DeRoyal Gauze, Internal, X-ray Detectable - DeRoyal Catheter, Continuous Irrigation - DeRoyal Clamp, Vascular - DeRoyal Joint, Shoulder, External Limb Component - DeRoyal Collector, Urine, (And Accessories) for Indwelling Catheter - DeRoyal Appliance, Fixation, Spinal Intervertebral Body - DeRoyal Sponge, Ophthalmic - DeRoyal Pad, Menstrual, Unscented - DeRoyal Marker, Skin - DeRoyal Catheter, Upper Urinary Tract - DeRoyal Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene - DeRoyal Hemostat - DeRoyal Splint, Hand, and Components - DeRoyal WRIST Thermometer, Electronic, Clinical - DeRoyal Kit, I.V. Start - DeRoyal Catheter, Conduction, Anesthetic - DeRoyal Handle, Scalpel - DeRoyal Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) - DeRoyal Wrap, Sterilization - DeRoyal Needle, Suturing, Disposable - DeRoyal Caliper, Ophthalmic - DeRoyal Container, Specimen, Sterile - DeRoyal Catheter, Urethral - DeRoyal Staple, Implantable - DeRoyal Punch, Surgical - DeRoyal System, X-Ray, Fluoroscopic, Image-Intensified - DeRoyal Catheter, Cannula and Tubing, Vascular, Cardiopulmonary bypass - DeRoyal Coagulator, Laparoscopic, Unipolar (and accessories) - DeRoyal Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass - DeRoyal Needle, Hypodermic, Single Lumen - DeRoyal Needle, Conduction, Anesthetic (W/WO Introducer)- DeRoyal Lamp, Surgical - DeRoyal Dressing, Wound, Hydrophilic - DeRoyal Staple, Removable (Skin) - DeRoyal Laparoscope General and Plastic Surgery - DeRoyal Spinal Vertebral Body Replacement Device - DeRoyal Culture Media, Non-Selective and Non-Differential - DeRoyal Toothbrush, Manual - DeRoyal Negative Pressure Wound Therapy Powered Suction Pump - DeRoyal Stimulator, Nerve, Transcutaneous, For Pain Relief - DeRoyal Speculum, Vaginal, Metal - DeRoyal Accessories, Catheter - DeRoyal Orthosis, Lumbo-Sacral - DeRoyal Suture, Nonabsorbable, Silk - DeRoyal Bedding Disposable, Medical - DeRoyal Vinyl Patient Examination Glove - DeRoyal Catheter, Intravascular, Therapeutic, Short-Term less than 30 days - DeRoyal Surgeon's Gloves Surgeon's Gloves - DeRoyal Gauze/Sponge, Internal, X-Ray Detectable - DeRoyal Tourniquet Kit - DeRoyal Clean-up Kit - DeRoyal Component, Traction, Non-Invasive - DeRoyal Joint, Ankle, External Brace - DeRoyal Apparatus, Suction, Single Patient Use, Portable, Nonpowered - DeRoyal Container, Specimen, Non-Sterile - DeRoyal Minor Surgical Procedures Tray - DeRoyal General Surgery Tray (Kit) - DeRoyal General Surgery Tray - DeRoyal Electrode, Pacemaker, Temporary - DeRoyal Cover, Barrier, Protective - DeRoyal Dressing Change Tray - DeRoyal Neurosurgical Paddie - DeRoyal Exercise, Powered - DeRoyal Lavage, Jet - DeRoyal Catheter,Urological - DeRoyal Device, Fixation, Tracheal Tube - DeRoyal Cannula Vial Access - DeRoyal Tubing, Pump, Cardiopulmonary Bypass - DeRoyal System, Thermal Regulating - DeRoyal Device, Intravascular Catheter Securement - DeRoyal Gauze/Sponge, Internal - DeRoyal Dissector, Surgical, General & Plastic Surgery - DeRoyal Adaptor, Grooming - DeRoyal Speculum, Vaginal, Nonmetal - DeRoyal Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass - DeRoyal Clip, Removable (Skin)- DeRoyal Patch, Pledget and Intracardiac, PTTP, PTFE, Polypropylene - DeRoyal Apparatus, Exhaust, Surgical - DeRoyal Cardiovascular Surgical Instruments Tray - DeRoyal Catheter, Cholangiography - DeRoyal Urinary Drainage Collection Kit, for Indwelling Catheter - DeRoyal Tape and Bandage, Adhesive - DeRoyal Incubator, Neonatal - Warmer, Infant Radiant - DeRoyal Sheet, Burn - DeRoyal Central Venous Catheter Dressing Change Kit - DeRoyal Anesthesia Conduction Kit - DeRoyal Table, Cystometric, Electric - DeRoyal Medical Glove, Specialty - DeRoyal Blade, Saw, Surgical,Cardiovascular FZT - Cutter, Surgical - DeRoyal Fiber, Medical, Absorbent - DeRoyal Circumcision Tray - DeRoyal Trap, Sterile Specimen - DeRoyal Tubes, Vacuum Sample, with Anticoagulant - DeRoyal Syringe Piston - DeRoyal Hook, Tracheal - DeRoyal Blade, Scalpel - DeRoyal Gastroenterology - Urology - DeRoyal Dressing, Compression - DeRoyal Sound, Uterine - DeRoyal Insufflator, Laparoscopic - DeRoyal Sigmoidoscope and Accessories, Flexible/Rigid - DeRoyal Suture Kit - DeRoyal Insoles, Medical - DeRoyal Instruments, Surgical, Cardiovascular - DeRoyal BedPan - DeRoyal Razor, Surgical - DeRoyal Circuit, Breathing (w Connector, Adaptor, Y Piece) - DeRoyal Blade, Saw, General & Plastic Surgery, Surgical - DeRoyal Stethoscope, Esophageal, with Electrical Conductors - DeRoyal Drape, Patient, Ophthalmic - DeRoyal System, irrigation, Urological - DeRoyal Accessories, Traction - DeRoyal Laparoscope, Gynecologic (and accessories) - DeRoyal Shield, Eye, Ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) - DeRoyal Dressing, Wound, Drug - DeRoyal / Dressing, Wound and Burn, Hydrogel w/Drug and/or Biologic - DeRoyal Silver Alginate Cath Patch Dressing - DeRoyal General surgery tray - DeRoyal Joint, Knee, External Brace - DeRoyal Restraint, Protective - DeRoyal Suture, Nonabsorbable - DeRoyal Support, Patient Position - DeRoyal Burn Kit without Drug - DeRoyal Electrode, Cutaneous - DeRoyal Retractor - DeRoyal Hemostat, Surgical - DeRoyal Labor and Delivery Kit - DeRoyal Stopcock, IV Set - DeRoyal Ortho Manual Surgical Instrument - DeRoyal Kit, Pelvic Exam - DeRoyal Accessory Surgical Apparel - DeRoyal Specula, Ophthalmic - DeRoyal Suture, Surgical, Absorbable, Polydioxanone - DeRoyal Tubing, Fluid Delivery - DeRoyal Cover, Limb - DeRoyal Cannula, Surgical, General & Plastic Surgery - DeRoyal Carrier, Ligature - DeRoyal Scalpel, One-Piece - DeRoyal Orthosis, Spinal Pedicle Fixation Orthosis, Spinal Pedicle Fixation, for Degenerative Disc Disease - DeRoyal General Purpose Dental Tray - DeRoyal Suture, Nonabsorbable, Synthetic, Polypropylene - DeRoyal Dressing, Wound and Burn, Occlusive - DeRoyal Splint, Extremity, Inflatable, External - DeRoyal Exerciser, Non-Measuring - DeRoyal Bandage, Liquid, Skin Protectant - DeRoyal Thermometer, electronic, clinical - DeRoyal Table, Cysto, Non-Electrical - DeRoyal Anesthesia Breathing Circuit Kit (Adult & Pediatric) - DeRoyal Support, Arm - DeRoyal Applier, Surgical, Clip - DeRoyal Catheter, Urological (antimicrobial) and Accessories - DeRoyal Splint, Abduction, Congenital Hip Dislocation - DeRoyal Electrode Electrocardiograph - DeRoyal Monitor, Bed Patient - DeRoyal Surgical Drape - DeRoyal Streamway Ear, Nose, and Throat Surgical Tray - DeRoyal IMD - Pack, Hot or Cold, Disposable - DeRoyal Gynecological Laparoscopic Kit - DeRoyal Suture, Absorbable, Synthetic, Polyglycolic Acid - Suture, Absorbable, Synthetic - DeRoyal Orthosis, Rib Fracture, Soft - DeRoyal BLOOD PRESSURE CUFF - DeRoyal Garment, Protective, for Incontinence - DeRoyal MICROSCOPE SLIDES - DeRoyal DEROYAL THERMO-COLD S Pack, Hot and Cold, Disposable - DeRoyal Scissors, General, Surgical - DeRoyal Syringe, Irrigating (Non Dental) - DeRoyal Bandage, Cast - DeRoyal Suture, Absorbable, Synthetic - DeRoyal applier, Surgical, Clip - DeRoyal Dressing, Wound, Collagen - DeRoyal Aspiration Tray (Kit) - DeRoyal Tubing/Tubing with Filter, Insufflation, Laparoscopic - DeRoyal Instrument, Ligature Passing & Knot Typing - DeRoyal Shoe, Cast - DeRoyal Protector, Skin Pressure - DeRoyal Cesarean Section Kit - DeRoyal Transducer, Pressure, Catheter Tip - DeRoyal Needle, Conduction, Anesthetic (W/WO Introducer) - DeRoyal Orthosis, Cervical - Thoracic, Rigid - DeRoyal Bag, Ice - DeRoyal Device, Occlusion, Umbilical - DeRoyal Monitor, Line Isolation - DeRoyal Clip, Vascular - DeRoyal Electrocautery, Gynecologic (and Accessories) - DeRoyal Depressor, Tongue, Non-Surgical - DeRoyal Tubing, Pressure and Accessories - DeRoyal Splint, Clavicle - DeRoyal Knife, Ophthalmic - DeRoyal Anti Fog Solution and Accessories, Endoscopy - DeRoyal Scissors, Medical, Disposable - DeRoyal Component, External, Limb, Ankle/Foot - DeRoyal Bandage, Liquid - DeRoyal Catheter, Irrigation - DeRoyal Splint, Traction - DeRoyal Stax Container, Liquid Medication, Graduated - DeRoyal Cane - DeRoyal Polymer Patient Examination Glove - DeRoyal Syringe, Piston - Needle, Hypodermic, Single Lumen - DeRoyal Trephine, Manual, Ophthalmic - DeRoyal Strip, Temperature, Forehead, Liquid Crystal - DeRoyal Sensostrip Temperature Sensor Halter, Head, Traction - DeRoyal Catheters, Suction, Tracheobronchial - DeRoyal Forceps, Ophthalmic - DeRoyal Dilator, Vessel, for Percutaneous Catheterization - DeRoyal Hood, Surgical - DeRoyal System, Imaging, Pulsed Echo, Ultrasonic - DeRoyal Catheter and Tip, Suction - DeRoyal Oxygenator, Cardiopulmonary Bypass - DeRoyal Solvent, Adhesive Tape - DeRoyal Holder, Needle, Gastroenterologic - DeRoyal Applicator, Absorbent Tipped, Non-Sterile - DeRoyal Device, Specimen Collection - DeRoyal Orthosis, Corrective Shoe - DeRoyal Tray, Surgical, Instrument - DeRoyal Cannula, Ophthalmic - DeRoyal Pad, Alcohol, Device Disinfectant - DeRoyal Bandage, Elastic - DeRoyal Surgical Table Cushion - DeRoyal Snare, Surgical - DeRoyal Forceps - DeRoyal Sampler, Amniotic Fluid (Amniocentesis Tray) - DeRoyal Tray, Surgical - DeRoyal Accessory, Surgical Apparel - DeRoyal Pack, Hot or Cold, Water Circulating - DeRoyal Clip, Implantable - Add Basin, Emesis - DeRoyal Orthosis, Cervical - DeRoyal Warmer, Infant Radiant - DeRoyal Needle, Conduction, Anesthetic (w/wo Introducer)- DeRoyal Anesthesia Conduction Kit - Needle, Conduction, Anesthetic (w/wo Introducer) - DeRoyal Clamp, Surgical, General & Plastic Surgery - DeRoyal Hook, Surgical, General & Plastic Surgery - DeRoyal Catheter, Urological (Antimicrobial) and Accessories - DeRoyal Tape, Measuring, Rulers and Calipers - DeRoyal Holder, Needle; Orthopedic - DeRoyal Laryngoscope, Endoscope - DeRoyal Stocking, Elastic - DeRoyal Wax, Bone - DeRoyal Pneumoperitoneum Needle - DeRoyal Kit, Wound Dressing - DeRoyal Adaptor, Dressing - DeRoyal Blood Pressure Cuff - DeRoyal Probe - DeRoyal Device, Transfer, Patient, Manual - DeRoyal Nerve Block Tray (Kit) - DeRoyal Pad, Neonatal Eye - DeRoyal Angiography/Angioplasty Kit - DeRoyal Instrument, Cranioplasty Material Forming - DeRoyal Dressing, Wound, Drug - Burn, Hydrogel w/Drug and/or Biologic - DeRoyal Accessories, Cleaning Brushes, for Endoscope - DeRoyal Dilator, Urethral Syringe, Balloon Inflation - DeRoyal Eye Tray - DeRoyal Drape, surgical - DeRoyal Unit, Filter, Membrane - DeRoyal Applicator, Absorbent Tipped, Sterile - DeRoyal Tourniquet, Pneumatic - DeRoyal Lift, Patient, Non-AC-Powered - DeRoyal Forceps, General & Plastic Surgery - DeRoyal Bottle, Collection, Vacuum - DeRoyal Syringe, balloon inflation - DeRoyal Balloon, Epistaxis - DeRoyal Stapler, Skin - DeRoyal Blood and Urine Collection Kit (Excludes HIV Testing) - DeRoyal Dilator, Vessel, Surgical - DeRoyal Tube, Aspirating, Flexible, Connecting - DeRoyal Stocking, Medical Support (For General Medical Purposes) - DeRoyal Agent, Absorbable Hemostatic, Non-Collagen Based - DeRoyal Dispenser, Liquid Medication - DeRoyal Clip, Scalp - DeRoyal Gas Mask-Anesthesia - DeRoyal Tissue Adhesive for the Topical Approximation of Skin - DeRoyal Tourniquet, Nonpneumatic - DeRoyal Grounding Pad Needle, Catheter - DeRoyal Catheter, Peritoneal - DeRoyal Gauze/Sponge, Nonresorbable for External Use - DeRoyal Catheter, Intravascular, Therapeutic, Short-term Less than 30 days - DeRoyal Unit, Suction Operatory - DeRoyal Catheter, Retention Type, Balloon - DeRoyal Cannula, Manipulator/Injector, Uterine - DeRoyal Cystotome - DeRoyal Binder, Abdominal - DeRoyal Syringe, piston - DeRoyal Catheter, Intravascular, Therapeutic, short-term less than 30 days - DeRoyal Pack, Hot or Cold, Reuseable - DeRoyal Pad, Eye - DeRoyal Drape, Surgical, Exempt - DeRoyal Amniotome - DeRoyal Pump, Portable, Aspiration (Manual or Powered) - DeRoyal Catheter, Coude - DeRoyal Camera, Surgical and Accessories - DeRoyal Filter, Bacterial, Breathing - Circuit - DeRoyal Pro-II NPWT Powered Suction Pump, Collection canisters, hoses, Y-connectors & tubing, and foam/gauze dressings – DeRoyal Joint, Elbow, External Limb Component, Mechanical - DeRoyal Laparoscopic Accessories, Gynecologic - DeRoyal Tubes, Gastrointestinal (and Accessories) - DeRoyal Catheter, Angioplasty, Peripheral, Transluminal - DeRoyal Syringe, Periodontic, Endodontic, Irrigating - DeRoyal Cotton, Roll - DeRoyal Catheter Umbilical Artery - DeRoyal Container, I V - DeRoyal Needle, Aspiration and Injection, Disposable - DeRoyal Cannula, surgical, General & Plastic Surgery - DeRoyal Hysterectomy Kit - DeRoyal Label OR Tag, Sterile - DeRoyal Cardiovascular Procedure Kit - DeRoyal Walker, Mechanical - DeRoyal Instrument, Surgical, Disposable - DeRoyal Apparatus, Traction, Non-Powered - DeRoyal Kit, Surgical Instrument, Disposable - DeRoyal Container, Specimen Mailer and Storage, Sterile - DeRoyal Triss. Umbilical - DeRoyal Bag, Urine Collection, Leg, For External Use, Non-Sterile - DeRoyal Transducer, Ultrasonic, Diagnostic - DeRoyal Instrument, Manual, Surgical, General Use - DeRoyal Jelly, Lubricating, For Transurethral Surgical Instrument - DeRoyal Nepcell Infant Heel Warmer (Chemical Heat Pack) - DeRoyal Tube, Feeding - DeRoyal

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device