DEROYAL INDUSTRIES, INC.

FDA Device Registration & Listing · POWELL, TN, US · Registration 1043214

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1043214
FEI Number
1043214
Entity Name
DEROYAL INDUSTRIES, INC.
City/State/Country
POWELL, TN, US
Establishment Address
200 DEBUSK LN., POWELL, TN 37849, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
DEROYAL INDUSTRIES, INC. (Owner Number: 1044833)
Owner / Operator Contact Address
200 DEBUSK LN., --, Powell, TN 37849, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered 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 Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Set, Administration, Intravascular - DeRoyal Dressing, Wound, Drug - DeRoyal Tubes, Vials, Systems, Serum Separators, Blood Collection - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Catheter, Intravascular, Diagnostic - DeRoyal Laparoscope, General & Plastic Surgery - DeRoyal Bag, Intestine - DeRoyal Orthosis, Truncal/Orthosis, Limb - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - 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 Connector, Catheter - DeRoyal Accessory Equipment, Cardiopulmonary Bypass - DeRoyal Crutch - DeRoyal Set, Administration, Intravascular - DeRoyal Orthosis, Limb Brace - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Yankauer - DeRoyal Skin Prep Tray (Kit)- DeRoyal Syringe, Piston - 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 Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Wire, Guide, Catheter - DeRoyal Condom - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Introducer, Catheter - DeRoyal Bed, Ac-Powered Adjustable Hospital - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - 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 Dressing, Wound, Drug - DeRoyal Catheter, Straight - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Bag, Reservoir - DeRoyal Aid, Transfer - DeRoyal Set, Administration, Intravascular - 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 Electrosurgical, Cutting & Coagulation & Accessories - 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 Dressing, Wound, Drug - DeRoyal Set, Administration, Intravascular - DeRoyal Gown, Surgical - DeRoyal Pad, Menstrual, Unscented - DeRoyal Marker, Skin - DeRoyal Set, Administration, Intravascular - 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 Sponge, Ophthalmic - DeRoyal Caliper, Ophthalmic - DeRoyal Container, Specimen, Sterile - DeRoyal Catheter, Urethral - DeRoyal Staple, Implantable - DeRoyal Punch, Surgical - DeRoyal Set, Administration, Intravascular - DeRoyal Syringe, Piston - DeRoyal Introducer, Catheter - 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 Thermometer, Electronic, Clinical - DeRoyal Needle, Hypodermic, Single Lumen - DeRoyal Needle, Conduction, Anesthetic (W/WO Introducer)- DeRoyal Lamp, Surgical - DeRoyal Dressing, Wound, Hydrophilic - DeRoyal Injector and Syringe, Angiographic - DeRoyal Staple, Removable (Skin) - DeRoyal Syringe, Piston - 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 Syringe, Piston - DeRoyal Drape, Surgical - DeRoyal Gown, Surgical - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Suture, Nonabsorbable, Silk - DeRoyal Bedding Disposable, Medical - DeRoyal Vinyl Patient Examination Glove - DeRoyal Catheter, Intravascular, Therapeutic, Short-Term less than 30 days - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - 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 Catheter, Intravascular, Diagnostic - DeRoyal Apparatus, Suction, Single Patient Use, Portable, Nonpowered - DeRoyal Container, Specimen, Non-Sterile - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Minor Surgical Procedures Tray - DeRoyal General Surgery Tray (Kit) - DeRoyal General Surgery Tray - DeRoyal Electrode, Pacemaker, Temporary - DeRoyal Dressing, Wound, Hydrophilic - DeRoyal Cover, Barrier, Protective - DeRoyal Catheter, Urological - DeRoyal Suture, Nonabsorbable, Silk - DeRoyal Dressing Change Tray - DeRoyal Gown, Surgical - DeRoyal Neurosurgical Paddie - DeRoyal Exercise, Powered - DeRoyal Drape, Surgical - DeRoyal Lavage, Jet - DeRoyal Catheter,Urological - DeRoyal Suture, Nonabsorbable, Silk - DeRoyal Device, Fixation, Tracheal Tube - DeRoyal Gown, Surgical - DeRoyal Cannula Vial Access - DeRoyal Injector and Syringe, Angiographic - DeRoyal Catheter, Intravascular, Diagnostic - DeRoyal Drape, Surgical - DeRoyal Tubing, Pump, Cardiopulmonary Bypass - DeRoyal Drape, Surgical - DeRoyal System, Thermal Regulating - DeRoyal Device, Intravascular Catheter Securement - DeRoyal Gauze/Sponge, Internal - DeRoyal Laparoscope, General & Plastic Surgery - DeRoyal Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass - 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 Needle, Hypodermic, Single Lumen - DeRoyal Syringe, Piston - DeRoyal Cardiovascular Surgical Instruments Tray - DeRoyal Catheter, Cholangiography - DeRoyal Urinary Drainage Collection Kit, for Indwelling Catheter - DeRoyal Tape and Bandage, Adhesive - DeRoyal Injector and Syringe, Angiographic - DeRoyal Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass - 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 Syringe, Piston - DeRoyal Medical Glove, Specialty - DeRoyal Mask, Surgical - DeRoyal Blade, Saw, Surgical,Cardiovascular FZT - Cutter, Surgical - DeRoyal Clamp, Vascular - DeRoyal Fiber, Medical, Absorbent - DeRoyal Circumcision Tray - DeRoyal Trap, Sterile Specimen - DeRoyal System, X-Ray, Fluoroscopic, Image-Intensified - DeRoyal Gown, Surgical - DeRoyal Tubes, Vacuum Sample, with Anticoagulant - DeRoyal Syringe Piston - DeRoyal Hook, Tracheal - DeRoyal System, Thermal Regulating - DeRoyal Drape, Surgical - DeRoyal Set, Administration, Intravascular - DeRoyal Blade, Scalpel - DeRoyal Gastroenterology - Urology - DeRoyal Negative Pressure Wound Therapy Powered Suction Pump - DeRoyal Dressing, Compression - DeRoyal Injector and Syringe, Angiographic - DeRoyal Gown, Surgical - DeRoyal Set, Administration, Intravascular - DeRoyal Sound, Uterine - DeRoyal Insufflator, Laparoscopic - DeRoyal Sigmoidoscope and Accessories, Flexible/Rigid - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Suture Kit - DeRoyal Insoles, Medical - DeRoyal Laparoscope, General & Plastic Surgery - DeRoyal Clip, Implantable - DeRoyal Instruments, Surgical, Cardiovascular - DeRoyal BedPan - DeRoyal Needle, Hypodermic, Single Lumen - 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 Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal System, irrigation, Urological - DeRoyal Drape, Surgical - DeRoyal Gown, Surgical - DeRoyal Accessories, Traction - DeRoyal Laparoscope, Gynecologic (and accessories) - DeRoyal Collector, Urine, (And Accessories) for Indwelling Catheter - DeRoyal Speculum, Vaginal, Nonmetal - 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, Silk - DeRoyal Suture, Nonabsorbable - DeRoyal Support, Patient Position - DeRoyal Burn Kit without Drug - DeRoyal Electrode, Cutaneous - DeRoyal Retractor - DeRoyal Hemostat, Surgical - DeRoyal Wrap, Sterilization - DeRoyal Catheter, Cannula and Tubing, Vascular, Cardiopulmonary By Pass - DeRoyal Labor and Delivery Kit - DeRoyal Needle, Hypodermic, Single Lumen - DeRoyal Catheter, Cannula and Tubing, Vascular, Cardiopulmonary bypass - DeRoyal Stopcock, IV Set - DeRoyal Set, Administration, Intravascular - DeRoyal Ortho Manual Surgical Instrument - DeRoyal Drape, Surgical - DeRoyal Kit, Pelvic Exam - DeRoyal Accessory Surgical Apparel - DeRoyal Stopcock, IV Set - DeRoyal Tubing, Pump, Cardiopulmonary Bypass - DeRoyal Specula, Ophthalmic - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Laparoscope, General & Plastic Surgery - DeRoyal Suture, Surgical, Absorbable, Polydioxanone - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Tubing, Fluid Delivery - DeRoyal Cover, Limb - DeRoyal Cannula, Surgical, General & Plastic Surgery - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Syringe, Piston - 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 Electrosurgical, Cutting & Coagulation & Accessories - 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 Stethoscope, Esophageal, with Electrical Conductors - DeRoyal Table, Cysto, Non-Electrical - DeRoyal Anesthesia Breathing Circuit Kit (Adult & Pediatric) - DeRoyal Needle, Hypodermic, Single Lumen - DeRoyal Surgeon's Gloves - DeRoyal Support, Arm - DeRoyal Applier, Surgical, Clip - DeRoyal Catheter, Urological (antimicrobial) and Accessories - DeRoyal Insufflator, Laparoscopic - DeRoyal Catheter, Intravascular, Diagnostic - DeRoyal Splint, Abduction, Congenital Hip Dislocation - DeRoyal Electrode Electrocardiograph - DeRoyal Wire, Guide, Catheter - DeRoyal Suture, Absorbable, Synthetic, Polyglycolic Acid - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Monitor, Bed Patient - DeRoyal Clamp, Vascular - DeRoyal Clip, Implantable - DeRoyal Surgical Drape - DeRoyal Streamway Ear, Nose, and Throat Surgical Tray - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal IMD - Pack, Hot or Cold, Disposable - DeRoyal Gynecological Laparoscopic Kit - DeRoyal Lubricant, Patient - 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 Catheter, Upper Urinary Tract - DeRoyal Dressing, Wound, Drug - DeRoyal Multidex Scissors, General, Surgical - DeRoyal Syringe, Irrigating (Non Dental) - DeRoyal Bandage, Cast - DeRoyal Suture, Absorbable, Synthetic - DeRoyal applier, Surgical, Clip - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - 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 Clamp, Vascular - DeRoyal Medical Glove, Specialty - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Orthosis, Cervical - Thoracic, Rigid - DeRoyal System, Thermal Regulating - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Bag, Ice - DeRoyal Device, Occlusion, Umbilical - DeRoyal Dressing, Wound, Drug - DeRoyal Instruments, Surgical, Cardiovascular - DeRoyal Drape, Surgical - DeRoyal Monitor, Line Isolation - DeRoyal Drape, Surgical - 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 Gauze/Sponge, Internal - DeRoyal Thermometer, Electronic, Clinical - DeRoyal Accessories, Catheter - DeRoyal Container, Liquid Medication, Graduated - DeRoyal Gauze/Sponge, Internal, X-Ray Detectable - 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 Laparoscope, General & Plastic Surgery - DeRoyal Forceps, Ophthalmic - DeRoyal Dilator, Vessel, for Percutaneous Catheterization - DeRoyal Hood, Surgical - DeRoyal Medical Glove, Specialty - DeRoyal System, Imaging, Pulsed Echo, Ultrasonic - DeRoyal Catheter and Tip, Suction - DeRoyal System, Thermal Regulating - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Injector and Syringe, Angiographic - DeRoyal Oxygenator, Cardiopulmonary Bypass - DeRoyal Solvent, Adhesive Tape - DeRoyal Holder, Needle, Gastroenterologic - DeRoyal Applicator, Absorbent Tipped, Non-Sterile - DeRoyal Apparatus, Suction, Single Patient Use, Portable, Nonpowered - DeRoyal Device, Specimen Collection - DeRoyal Orthosis, Corrective Shoe - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Suture, Absorbable, Synthetic, Polyglycolic Acid - DeRoyal Suture, Nonabsorbable, Silk - DeRoyal Set, Administration, Intravascular - DeRoyal Gown, Surgical - DeRoyal Tray, Surgical, Instrument - DeRoyal Cannula, Ophthalmic - DeRoyal Pad, Alcohol, Device Disinfectant - DeRoyal Dressing, Wound, Occlusive - DeRoyal Wrap, Sterilization - DeRoyal Catheter, Urological - DeRoyal Bandage, Elastic - DeRoyal Thermometer, Electronic, Clinical - DeRoyal Stimulator, Nerve, Transcutaneous, For Pain Relief - DeRoyal Transducer, Blood-Pressure, Extravascular - DeRoyal Surgical Table Cushion - DeRoyal Snare, Surgical - DeRoyal Drape, Surgical - DeRoyal Forceps - DeRoyal Sampler, Amniotic Fluid (Amniocentesis Tray) - DeRoyal Tray, Surgical - DeRoyal Accessory, Surgical Apparel - DeRoyal Catheter, Urological - 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 Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Holder, Needle; Orthopedic - DeRoyal Catheter, Intravascular, Diagnostic - DeRoyal Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene - DeRoyal Laryngoscope, Endoscope - DeRoyal Syringe, Piston - DeRoyal Stopcock, IV Set - DeRoyal Set, Administration, Intravascular - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Stocking, Elastic - DeRoyal Wax, Bone - DeRoyal

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic Unknown Class U N/A 2010-08-23
FDE Laparoscopy Kit Gastroenterology, Urology Class 2 876.1500 2016-03-07
KID Restraint, Wheelchair, Non-Protective Physical Medicine Class 1 890.3910 2005-08-08
FRO Dressing, Wound, Drug Unknown Class U N/A 2016-07-20
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2022-06-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-11-15
MCZ Suture Removal Kit General, Plastic Surgery Class 1 878.4800 2015-12-10
GDF Guide, Needle, Surgical General, Plastic Surgery Class 1 878.4800 2016-01-27
FMF Syringe, Piston General Hospital Class 2 880.5860 2024-07-18
BYG Mask, Oxygen Anesthesiology Class 1 868.5580 2016-01-13
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-05-11
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-01-27
HRX Arthroscope Orthopedic Class 2 888.1100 2016-01-27
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2024-05-23
OGK Orotracheal Intubation Guide Kit Anesthesiology Class 2 868.1400 2020-08-17
KMJ Lubricant, Patient General Hospital Class 1 880.6375 2024-06-17
GDT Staple, Removable (Skin) General, Plastic Surgery Class 1 878.4760 2024-05-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2015-12-30
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-08-26
FRO Dressing, Wound, Drug Unknown Class U N/A 2015-11-06
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2012-09-17
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-01-27
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2021-02-23
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2009-08-24
KGY Bag, Intestine General, Plastic Surgery Class 1 878.4100 2012-11-02
MRI Orthosis, Truncal/Orthosis, Limb Physical Medicine Class 1 890.3490 2015-09-16
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-12-04
FRQ Tube, Levine Gastroenterology, Urology Class 2 876.5980 2025-06-17
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2015-11-10
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2014-02-27
CAE Airway, Oropharyngeal, Anesthesiology Anesthesiology Class 1 868.5110 2012-09-28
OHL Pap Smear Kit Obstetrics/Gynecology Class 2 884.4530 2016-03-07
FEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation Gastroenterology, Urology Class 2 876.5980 2013-08-26
GCD Connector, Catheter General, Plastic Surgery Class 1 878.4200 2012-09-25
HXD Clamp General, Plastic Surgery Class 1 878.4800 2006-08-22
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2024-05-23
GCD Connector, Catheter General, Plastic Surgery Class 1 878.4200 2024-05-24
KRI Accessory Equipment, Cardiopulmonary Bypass Cardiovascular Class 1 870.4200 1997-12-10
IPR Crutch Physical Medicine Class 1 890.3150 2010-03-18
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-08-26
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 2006-06-20
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-01-26
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered General Hospital Class 2 880.6740 2003-04-04
OJU Skin Prep Tray General, Plastic Surgery Class 1 878.4800 2016-03-07
FMF Syringe, Piston General Hospital Class 2 880.5860 2016-01-14
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2012-09-04
HAM Apparatus, Electrosurgical General, Plastic Surgery Class 2 878.4400 2022-07-18
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-07-18
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2022-08-17
NGT Saline, Vascular Access Flush General Hospital Class 2 880.5200 2024-01-16
IMP Cushion, Wheelchair Physical Medicine Class 1 890.3920 1999-05-21
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2024-12-13
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2024-05-23
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2012-09-04
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered General Hospital Class 2 880.6740 2013-02-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-12-19
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2016-01-14
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2012-09-28
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2017-11-01
FTA Light, Surgical, Accessories General, Plastic Surgery Class 2 878.4580 2015-09-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-08-06
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2015-11-09
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2012-09-17
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-01-27
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2012-08-28
FNL Bed, Ac-Powered Adjustable Hospital General Hospital Class 2 880.5100 2011-07-14
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-01-18
KSR Container, Empty, For Collection & Processing Of Blood & Blood Components Hematology Class 2 864.9100 2009-12-30
HRX Arthroscope Orthopedic Class 2 888.1100 2025-12-02
ILI Sling, Arm Physical Medicine Class 1 890.3640 2006-07-27
OKH Body Fluids Barrier Kit General, Plastic Surgery Class 2 878.4040 2016-02-08
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2024-05-23
GAZ Tubing, Noninvasive General Hospital Class 2 880.6740 2005-06-23
KPE Container, I.V. General Hospital Class 2 880.5025 2024-01-15
FXP Cover, Shoe, Operating-Room General, Plastic Surgery Class 1 878.4040 2016-02-08
FWZ Operating Room Accessories Table Tray General, Plastic Surgery Class 1 878.4950 2012-09-28
KHR Absorber, Saliva, Paper Dental Class 1 872.6050 2023-11-14
FRO Dressing, Wound, Drug Unknown Class U N/A 2024-07-23
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2023-10-16
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-02-20
BTC Bag, Reservoir Anesthesiology Class 1 868.5320 2012-09-28
IKX Aid, Transfer Physical Medicine Class 1 890.5050 2012-08-27
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2024-12-13
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2023-05-31
FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) Gastroenterology, Urology Class 2 876.5130 2015-11-20
KNX Collector, Urine, (And Accessories) For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2015-11-20
GDY Gauze/Sponge, Internal, X-Ray Detectable General, Plastic Surgery Class 1 878.4450 2024-08-09
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-10-31
GBQ Catheter, Continuous Irrigation General, Plastic Surgery Class 1 878.4200 2015-11-09
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2015-11-09
IQQ Joint, Shoulder, External Limb Component Physical Medicine Class 1 890.3420 1992-10-28
KNX Collector, Urine, (And Accessories) For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2024-12-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-02-27
HOZ Sponge, Ophthalmic Ophthalmic Class 2 886.4790 2015-09-17
FRO Dressing, Wound, Drug Unknown Class U N/A 2007-12-28
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-08-26
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2014-02-10
HHD Pad, Menstrual, Unscented Obstetrics/Gynecology Class 1 884.5435 2012-09-25
FZZ Marker, Skin General, Plastic Surgery Class 1 878.4660 2006-08-22
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-06-17
EYC Catheter, Upper Urinary Tract Gastroenterology, Urology Class 2 876.5130 2012-09-28
DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene Cardiovascular Class 2 870.3470 2024-02-19
HRQ Hemostat General, Plastic Surgery Class 1 878.4800 2006-08-22
ILH Splint, Hand, And Components Physical Medicine Class 1 890.3475 2006-06-20
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2016-07-01
LRS I.V. Start Kit General Hospital Class 2 880.5200 2015-12-10
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 2016-01-13
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2012-09-17
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4160 2024-04-25
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2022-06-14
GAB Needle, Suturing, Disposable General, Plastic Surgery Class 1 878.4800 1997-11-12
HOZ Sponge, Ophthalmic Ophthalmic Class 2 886.4790 2024-12-04
HOE Caliper, Ophthalmic Ophthalmic Class 1 886.4350 2012-09-25
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2004-03-03
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2021-11-04
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2024-05-23
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2025-04-10
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2024-07-08
MEA Pump, Infusion, Pca General Hospital Class 2 880.5725 2024-07-08
FMF Syringe, Piston General Hospital Class 2 880.5860 2016-01-14
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-01-20
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2014-02-10
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2024-12-13
HFG Coagulator, Laparoscopic, Unipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4160 2024-12-13
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2024-02-27
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2021-02-10
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2024-01-16
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2016-01-13
FTD Lamp, Surgical General, Plastic Surgery Class 2 878.4580 2015-09-17
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2021-09-20
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2025-03-12
GDT Staple, Removable (Skin) General, Plastic Surgery Class 1 878.4760 1991-07-15
FMF Syringe, Piston General Hospital Class 2 880.5860 2016-01-14
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2019-06-06
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2014-02-27
JSG Culture Media, Non-Selective And Non-Differential Microbiology Class 1 866.2300 2020-07-14
EFW Toothbrush, Manual Dental Class 1 872.6855 2006-08-22
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2017-05-10
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2019-01-07
HDF Speculum, Vaginal, Metal Obstetrics/Gynecology Class 1 884.4520 2024-05-24
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2004-06-23
IPY Orthosis, Lumbo-Sacral Physical Medicine Class 1 890.3490 2006-06-20
FMF Syringe, Piston General Hospital Class 2 880.5860 2016-05-19
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2024-05-24
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2024-05-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-01-23
GAR Suture, Nonabsorbable, Synthetic, Polyamide General, Plastic Surgery Class 2 878.5020 2024-12-13
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2005-04-14
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2024-01-12
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2024-08-27
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2015-12-30
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2016-02-12
LWH Counter, Sponge, Surgical General Hospital Class 1 880.2740 2023-07-11
GDY Gauze/Sponge, Internal, X-Ray Detectable General, Plastic Surgery Class 1 878.4450 2023-07-11
OJS Tourniquet Kit General, Plastic Surgery Class 1 878.5900 2016-02-08
PWU Clean-Up Kit General Hospital Class 1 880.6890 2021-08-11
KQZ Component, Traction, Non-Invasive Orthopedic Class 1 888.5890 2006-08-22
ITW Joint, Ankle, External Brace Physical Medicine Class 1 890.3475 2005-08-08
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2008-12-17
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered General, Plastic Surgery Class 1 878.4680 2024-12-13
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2006-08-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-01-27
PYB Minor Surgical Procedures Tray General, Plastic Surgery Class 1 878.4800 2025-06-17
LRO General Surgery Tray General, Plastic Surgery Class 2 878.4370 2016-06-03
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 2013-08-26
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2004-06-23
MMP Cover, Barrier, Protective General, Plastic Surgery Class 2 878.4370 2011-09-19
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2024-12-13
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2013-08-26
OXQ Dressing Change Tray General Hospital Class 1 880.5075 2015-12-10
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2023-11-01
HBA Neurosurgical Paddie Neurology Class 2 882.4700 2016-01-27
BXB Exerciser, Powered Physical Medicine Class 1 890.5380 2015-09-16
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2013-09-05
FQH Lavage, Jet General Hospital Class 2 880.5475 2011-12-30
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2014-02-10
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2016-01-15
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2016-01-15
GAR Suture, Nonabsorbable, Synthetic, Polyamide General, Plastic Surgery Class 2 878.5020 2016-01-15
GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile General, Plastic Surgery Class 2 878.4495 2016-01-15
CBH Device, Fixation, Tracheal Tube Anesthesiology Class 1 868.5770 2005-08-08
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2024-05-30
FGY Cannula, Injection General, Plastic Surgery Class 1 878.4200 2016-03-07
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2017-04-19
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2007-12-19
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2024-05-23
DWE Tubing, Pump, Cardiopulmonary Bypass Cardiovascular Class 2 870.4390 2016-01-13
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2024-12-13
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2015-11-09
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2015-09-15
EFQ Gauze/Sponge, Internal Unknown Class U N/A 2010-01-29
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-05-23
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2013-12-24
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2001-08-03
ILW Adaptor, Grooming Physical Medicine Class 1 890.5050 2015-09-22
HIB Speculum, Vaginal, Nonmetal Obstetrics/Gynecology Class 2 884.4530 2015-09-17
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2015-09-22
FZQ Clip, Removable (Skin) General, Plastic Surgery Class 1 878.4320 2015-11-09
DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene Cardiovascular Class 2 870.3470 2022-08-15
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2016-01-14
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2016-01-14
FMF Syringe, Piston General Hospital Class 2 880.5860 2016-01-14
OFA Cardiovascular Surgical Instruments Tray Cardiovascular Class 1 870.4500 2021-05-24
GBZ Catheter, Cholangiography General, Plastic Surgery Class 1 878.4200 2014-02-10
FCN Urinary Drainage Collection Kit, For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2015-11-23
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2003-04-04
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2016-03-30
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2022-08-15
FMT Warmer, Infant Radiant General Hospital Class 2 880.5130 2012-04-25
FMZ Incubator, Neonatal General Hospital Class 2 880.5400 2012-04-25
FPY Sheet, Burn General Hospital Class 1 880.5180 2004-12-09
PEZ Central Venous Catheter Dressing Change Kit General Hospital Class 2 880.5200 2015-12-10
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2024-01-16
MMZ Table, Cystometric, Electric Gastroenterology, Urology Class 2 876.4890 2024-10-17
FMF Syringe, Piston General Hospital Class 2 880.5860 2016-01-14
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-05-29
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-05-29
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2021-10-26
DWH Blade, Saw, Surgical, Cardiovascular General, Plastic Surgery Class 1 878.4820 2016-01-13
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2017-04-19
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2011-05-05
FRL Fiber, Medical, Absorbent General Hospital Class 1 880.5300 2006-08-22
OHG Circumcision Tray Obstetrics/Gynecology Class 2 884.4530 2016-05-17
BYZ Trap, Sterile Specimen General Hospital Class 2 880.6740 2025-04-23
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2012-09-04
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2024-05-29
GIM Tubes, Vacuum Sample, With Anticoagulant Clinical Chemistry Class 2 862.1675 2016-01-27
FMF Syringe, Piston General Hospital Class 2 880.5860 2016-01-14
KCH Hook, Tracheal Ear, Nose, Throat Class 1 874.4420 2024-06-06
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2014-04-23
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2024-09-10
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-04-23
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 1998-08-19
LJH System, Irrigation, Urological Gastroenterology, Urology Class 2 876.5130 2024-05-23
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2025-12-02
MHW Dressing, Compression General Hospital Class 1 880.5075 2004-12-09
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2007-12-19
FYC Gown, Isolation, Surgical General, Plastic Surgery Class 2 878.4040 2024-05-23
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2024-05-23
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-06-04
HHM Sound, Uterine Obstetrics/Gynecology Class 1 884.4530 2024-05-24
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2013-05-22
FAM Sigmoidoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2012-09-26
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-12-05
OVN Suture Kit General, Plastic Surgery Class 2 878.4830 2016-02-08
KYS Insoles, Medical General Hospital Class 1 880.6280 2012-11-02
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-01-18
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2024-01-18
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2012-08-28
FOB Bedpan General Hospital Class 1 880.6730 2008-05-21
FMF Syringe, Piston General Hospital Class 2 880.5860 2022-08-22
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2022-08-22
LWK Razor, Surgical General, Plastic Surgery Class 1 878.4800 2012-09-20
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece) Anesthesiology Class 1 868.5240 2005-08-25
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2005-06-23
BZT Stethoscope, Esophageal, With Electrical Conductors Anesthesiology Class 2 868.1920 2020-04-28
HMT Drape, Patient, Ophthalmic General, Plastic Surgery Class 2 878.4370 2015-09-17
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-01-27
LJH System, Irrigation, Urological Gastroenterology, Urology Class 2 876.5130 2024-12-13
HRX Arthroscope Orthopedic Class 2 888.1100 2024-12-13
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2014-02-10
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2024-12-13
ILZ Accessories, Traction Physical Medicine Class 1 890.5925 2015-09-21
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2024-12-13
KNX Collector, Urine, (And Accessories) For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2024-05-24
HIB Speculum, Vaginal, Nonmetal Obstetrics/Gynecology Class 2 884.4530 2024-05-23
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 2012-09-25
MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic Unknown Class U N/A 2007-12-28
FRO Dressing, Wound, Drug Unknown Class U N/A 2007-12-28
LRO General Surgery Tray General, Plastic Surgery Class 2 878.4370 2016-03-07
ITQ Joint, Knee, External Brace Physical Medicine Class 1 890.3475 2006-06-20
FMQ Restraint, Protective General Hospital Class 1 880.6760 2015-09-15
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2016-01-15
GAO Suture, Nonabsorbable General, Plastic Surgery Class 2 878.4495 2016-01-15
CCX Support, Patient Position Anesthesiology Class 1 868.6820 2005-08-08
OJJ Burn Kit Without Drug General, Plastic Surgery Class 1 878.4022 2015-12-10
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2012-11-02
GAD Retractor General, Plastic Surgery Class 1 878.4800 2006-08-22
EMD Hemostat, Surgical Dental Class 1 872.4565 2024-05-02
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2024-01-08
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2016-02-12
MLS Labor And Delivery Kit Obstetrics/Gynecology Class 2 884.4530 2016-03-07
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2025-02-18
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2024-09-10
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2024-05-23
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2024-12-13
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2010-08-10
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2024-12-13
MLT Pelvic Exam Kit Obstetrics/Gynecology Class 2 884.4530 2016-05-17
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2021-07-20
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2024-05-23
DWE Tubing, Pump, Cardiopulmonary Bypass Cardiovascular Class 2 870.4390 2016-02-12
HNC Specula, Ophthalmic Ophthalmic Class 1 886.4350 2016-05-17
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-10-18
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-01-08
NEW Suture, Surgical, Absorbable, Polydioxanone General, Plastic Surgery Class 2 878.4840 2024-08-26
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-11-10
FPK Tubing, Fluid Delivery General Hospital Class 2 880.5440 2024-05-23
IPM Cover, Limb Physical Medicine Class 1 890.3025 2001-08-03
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2017-01-19
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2015-12-30
FMF Syringe, Piston General Hospital Class 2 880.5860 2012-09-04
GEJ Carrier, Ligature General, Plastic Surgery Class 1 878.4800 2016-01-27
GDX Scalpel, One-Piece General, Plastic Surgery Class 1 878.4800 2006-08-22
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-02-27
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-02-27
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-02-27
OFX General Purpose Dental Tray Dental Class 1 872.6640 2024-01-12
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2016-01-15
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-02-12
FRO Dressing, Wound, Drug Unknown Class U N/A 2013-01-30
FZF Splint, Extremity, Inflatable, External General, Plastic Surgery Class 1 878.3900 2014-07-29
ION Exerciser, Non-Measuring Physical Medicine Class 1 890.5370 1994-11-10
NEC Bandage, Liquid, Skin Protectant General Hospital Class 1 880.5090 2016-02-08
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2010-09-10
BZT Stethoscope, Esophageal, With Electrical Conductors Anesthesiology Class 2 868.1920 2016-10-24
EYH Table, Cysto, Non-Electrical Gastroenterology, Urology Class 1 876.4890 2012-09-25
OFP Anesthesia Breathing Circuit Kit (Adult & Pediatric) Anesthesiology Class 1 868.5240 2016-03-07
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2012-12-28
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2025-01-28
IOY Support, Arm Physical Medicine Class 1 890.3475 2015-09-21
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 2024-01-18
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2024-08-06
MJC Catheter, Urological (Antimicrobial) And Accessories Gastroenterology, Urology Class 2 876.5130 2024-08-06
OSV Insufflator, Endoscopic Vessel Harvesting Obstetrics/Gynecology Class 2 884.1730 2024-12-13
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2024-12-13
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2024-05-24
IOZ Splint, Abduction, Congenital Hip Dislocation Physical Medicine Class 1 890.3665 2015-09-21
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2024-12-13
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2025-06-06
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2016-01-15
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-12-27
KMI Monitor, Bed Patient General Hospital Class 1 880.2400 2014-02-10
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2016-01-13
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2014-08-01
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2024-01-15
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered General, Plastic Surgery Class 2 878.4780 2025-05-14
OGR Ear, Nose, And Throat Surgical Tray Ear, Nose, Throat Class 1 874.4420 2016-09-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-05-24
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2018-05-18
OHD Gynecological Laparoscopic Kit Obstetrics/Gynecology Class 2 884.1720 2016-03-07
KMJ Lubricant, Patient General Hospital Class 1 880.6375 2015-09-17
GAN Suture, Absorbable, Synthetic General, Plastic Surgery Class 2 878.4830 2016-01-15
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2016-01-15
IPX Orthosis, Rib Fracture, Soft Physical Medicine Class 1 890.3490 1994-08-18
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2006-06-20
EYQ Garment, Protective, For Incontinence Gastroenterology, Urology Class 1 876.5920 2016-01-13
KEW Slides, Microscope Pathology Class 1 864.3010 2004-07-12
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2006-08-09
EYC Catheter, Upper Urinary Tract Gastroenterology, Urology Class 2 876.5130 2020-11-19
FRO Dressing, Wound, Drug Unknown Class U N/A 2010-08-23
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2004-12-09
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 1997-10-23
ITG Bandage, Cast Physical Medicine Class 1 890.3025 2005-08-08
GAN Suture, Absorbable, Synthetic General, Plastic Surgery Class 2 878.4830 2024-01-17
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 2012-12-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-05-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-05-23
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2014-09-18
OJT Aspiration Tray General, Plastic Surgery Class 1 878.4800 2016-05-17
NKC Tubing/Tubing With Filter, Insufflation, Laparoscopic Obstetrics/Gynecology Class 1 884.1730 2009-08-21
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2004-12-09
IPG Shoe, Cast Physical Medicine Class 1 890.3025 2006-06-20
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2006-07-27
OHM Cesarean Section Tray Obstetrics/Gynecology Class 2 884.1720 2016-03-07
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2022-01-26
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2013-08-26
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2025-02-18
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-01-08
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-01-08
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2024-01-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-01-27
IQF Orthosis, Cervical-Thoracic, Rigid Physical Medicine Class 1 890.3490 2017-04-27
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2024-12-13
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2015-09-16
KYR Bag, Ice General Hospital Class 1 880.6050 1992-10-28
FOD Device, Occlusion, Umbilical General Hospital Class 1 880.5950 1997-02-12
SEL Securement Wound Dressing For Reduction Of Infection Unknown Class U N/A 2024-12-13
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2012-09-04
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2024-01-02
DRI Monitor, Line Isolation Cardiovascular Class 1 870.2620 2025-01-02
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2023-04-19
DSS Clip, Vascular Cardiovascular Class 2 870.3250 2025-04-10
HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.4120 2013-01-24
FMA Depressor, Tongue, Non-Surgical General Hospital Class 1 880.6230 2001-08-03
BYX Tubing, Pressure And Accessories Anesthesiology Class 1 868.5860 2012-09-20
IQJ Splint, Clavicle Physical Medicine Class 1 890.3490 2006-07-27
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2016-02-12
OCT Anti Fog Solution And Accessories, Endoscopy Gastroenterology, Urology Class 2 876.1500 2009-08-24
JOK Scissors, Medical, Disposable General Hospital Class 1 880.6820 1998-08-07
ISH Component, External, Limb, Ankle/Foot Physical Medicine Class 1 890.3420 1991-04-03
KMF Bandage, Liquid General Hospital Class 1 880.5090 2024-06-25
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2005-04-20
HSP Splint, Traction Orthopedic Class 1 888.5890 1997-01-13
EFQ Gauze/Sponge, Internal Unknown Class U N/A 2012-09-21
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2024-03-28
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2024-05-24
KYW Container, Liquid Medication, Graduated General Hospital Class 1 880.6430 2006-08-22
GDY Gauze/Sponge, Internal, X-Ray Detectable General, Plastic Surgery Class 1 878.4450 2006-08-22
IPS Cane Physical Medicine Class 1 890.3075 2015-09-16
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-05-23
FMF Syringe, Piston General Hospital Class 2 880.5860 2013-05-22
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2013-05-22
HRH Trephine, Manual, Ophthalmic Ophthalmic Class 1 886.4350 2024-07-18
KPD Strip, Temperature, Forehead, Liquid Crystal General Hospital Class 2 880.2200 1998-03-16
HSS Halter, Head, Traction Orthopedic Class 1 888.5890 2006-08-09
BSY Catheters, Suction, Tracheobronchial Anesthesiology Class 1 868.6810 2004-12-09
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-12-13
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 2024-08-14
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2012-09-04
FXY Hood, Surgical General, Plastic Surgery Class 2 878.4040 2025-05-29
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-05-23
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-02-08
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2024-12-13
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2015-11-09
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-01-27
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2020-11-30
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2012-12-28
KOX Solvent, Adhesive Tape General, Plastic Surgery Class 1 878.4730 2016-02-08
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 2012-09-17
KXF Applicator, Absorbent Tipped, Non-Sterile General Hospital Class 1 880.6025 2001-08-03
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered General, Plastic Surgery Class 1 878.4680 2001-08-03
LIO Device, Specimen Collection Microbiology Class 1 866.2900 2025-08-06
KNP Orthosis, Corrective Shoe Physical Medicine Class 1 890.3475 2006-06-20
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-01-27
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2014-07-30
GAL Suture, Absorbable, Natural General, Plastic Surgery Class 2 878.4830 2016-01-15
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2016-01-15
GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile General, Plastic Surgery Class 2 878.4495 2016-01-15
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2016-01-15
GAR Suture, Nonabsorbable, Synthetic, Polyamide General, Plastic Surgery Class 2 878.5020 2016-01-15
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2016-01-15
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2016-01-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-08-26
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2024-05-29
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2001-05-16
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2024-01-12
LKB Pad, Alcohol, Device Disinfectant Unknown Class U N/A 2016-02-08
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2004-12-09
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2024-05-15
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2023-09-29
FQM Bandage, Elastic General Hospital Class 1 880.5075 2006-08-09
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2022-09-22
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2012-11-16
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2025-08-26
LWG Surgical Table Cushion General, Plastic Surgery Class 1 878.4950 2006-07-27
GAE Snare, Surgical General, Plastic Surgery Class 1 878.4800 2005-09-28
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2024-05-24
HTD Forceps General, Plastic Surgery Class 1 878.4800 2006-08-22
HIO Sampler, Amniotic Fluid (Amniocentesis Tray) Obstetrics/Gynecology Class 1 884.1550 2016-11-10
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2001-02-06
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2005-08-25
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2015-11-10
ILO Pack, Hot Or Cold, Water Circulating Physical Medicine Class 2 890.5720 1997-02-28
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 2024-05-23
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2024-05-23
FNY Basin, Emesis General Hospital Class 1 880.6730 2001-05-16
IQK Orthosis, Cervical Physical Medicine Class 1 890.3490 2006-06-20
FMT Warmer, Infant Radiant General Hospital Class 2 880.5130 2020-07-21
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2015-11-10
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2012-09-04
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2012-09-04
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2024-07-23
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2024-07-18
MJC Catheter, Urological (Antimicrobial) And Accessories Gastroenterology, Urology Class 2 876.5130 2024-02-15
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2006-08-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-09-05
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2024-07-31
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2015-11-09
DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene Cardiovascular Class 2 870.3470 2025-06-09
GCI Laryngoscope, Endoscope Gastroenterology, Urology Class 2 876.1500 2025-01-20
FMF Syringe, Piston General Hospital Class 2 880.5860 2024-08-06
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2017-11-01
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2024-12-13
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2015-12-30
ILG Stocking, Elastic Physical Medicine Class 1 890.3475 2015-09-25
MTJ Wax, Bone Unknown Class U N/A 2016-02-08

Official Correspondent

Elizabeth Reed

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DEROYAL INDUSTRIES, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3008583452 DeRoyal Industries, Inc. Powell, TN, US
1051550 DEROYAL INDUSTRIES, INC. MAYNARDVILLE, TN, US
1057404 DeRoyal Industries, Inc. POWELL, TN, US
1034876 DEROYAL INDUSTRIES, INC. MAYNARDVILLE, TN, US
3021190810 DePre, LLC Powell, TN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K954741 Derma Sciences, Inc. DERMAGRAN WENT DRESSING (DEXTROSE-SALINE) 1995-11-01
K150256 Argentum Medical SILVERLON BURN CONTACT DRESSINGS 2015-04-30
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-05 DeRoyal Wound Care U
Aquasorb Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case, Catalog # 46-511, 2.5' x 2.5', labeled in part ***Sterile***Manufacturer: DeRoyal 200 Debusk Lane Powell, TN 37849 USA***
Z-0003-06 B. Braun Medical, Inc. U
D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025 3M Company Health Care Business 3m Center U
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0008-2008 Lemaitre Vascular, Inc. 2
CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Z-0039-05 Medrad Inc 2
Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT

Similar Registrations

Registration Number Establishment Name Location
3024971708 Carowinds Charlotte, NC, US
9680091 DERMA SCIENCES CANADA, INC (dba DERMA SCIENCES, INC.) TORONTO Ontario, CA
1058584 Sterigenics US LLC Charlotte, NC, US
1921846 Cardinal Health Hazelwood, MO, US
2132242 Stellen Medical, LLC Saint Paul, MN, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1043214. Last updated year: 2026. Please use registration number 1043214 when referencing this establishment in official correspondence.
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