Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1055236

FEI Number

1000112968

Entity Name

DEROYAL INDUSTRIES, INC.

City/State/Country

NEW TAZEWELL, TN, US

Establishment Address

1211 HWY. 33 SOUTH, NEW TAZEWELL, TN 37825, US

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

DEROYAL INDUSTRIES, INC. (Owner Number: 1044833)

Owner / Operator Contact Address

200 DEBUSK LN., --, Powell, TN 37849, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Clamp, Vascular - DeRoyal Punch, Surgical - DeRoyal Clip, Implantable - DeRoyal Sigmoidoscope and Accessories, Flexible/Rigid - DeRoyal Gown, Surgical - DeRoyal Catheter, Irrigation - DeRoyal Bandage, Elastic - DeRoyal Hood, Surgical - DeRoyal Container, Specimen Mailer and Storage, Sterile - DeRoyal Drape, Surgical - DeRoyal Hemostat, Surgical - DeRoyal Collector, Urine, (And Accessories) for Indwelling Catheter - DeRoyal Syringe, piston - DeRoyal Trap, Sterile Specimen - DeRoyal Laparoscope, Gynecologic (and accessories) - DeRoyal Drape, Surgical - DeRoyal Hook, Tracheal - DeRoyal Catheter, Upper Urinary Tract - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Tray, Surgical - DeRoyal Sound, Uterine - DeRoyal Clamp, Vascular - DeRoyal Monitor, Line Isolation - DeRoyal Light, Surgical, Accessories - DeRoyal Tubes, Gastrointestinal (and Accessories) - DeRoyal Thermometer, Electronic, Clinical - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Medical Glove, Specialty - DeRoyal Gown, Surgical - DeRoyal Gown, Surgical - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Label OR Tag, Sterile - DeRoyal Blade, Scalpel - DeRoyal Anesthesia Conduction Kit - DeRoyal Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass - DeRoyal Drape, Surgical, Exempt - DeRoyal Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene - DeRoyal Surgeon's Gloves - DeRoyal Caliper, Ophthalmic - DeRoyal Arthroscope - DeRoyal Clip, Implantable - DeRoyal Surgeon's Gloves - DeRoyal Gown, Surgical - DeRoyal Set, Administration, Intravascular - DeRoyal Streamway Catheter, Angioplasty, Peripheral, Transluminal - DeRoyal Instrument, Ligature Passing & Knot Typing - DeRoyal System, Thermal Regulating - DeRoyal Wax, Bone - DeRoyal Guide, Needle, Surgical - DeRoyal Clean-up Kit - DeRoyal Cannula, Ophthalmic - DeRoyal Incubator, Neonatal - Warmer, Infant Radiant - DeRoyal Accessories, Catheter - DeRoyal Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene - DeRoyal Drape, Surgical - DeRoyal Probe - DeRoyal Drape, Surgical - DeRoyal Scissors, Medical, Disposable - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Laparoscope General and Plastic Surgery - DeRoyal Apparatus, Suction, Single Patient Use, Portable, Nonpowered - DeRoyal Tubing, Noninvasive - DeRoyal Catheter, Urological - DeRoyal Clip, Implantable - DeRoyal Ear, Nose, and Throat Surgical Tray - DeRoyal Bedding Disposable, Medical - DeRoyal Eye Tray - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Sponge, Ophthalmic - DeRoyal Cardiovascular Surgical Instruments Tray - DeRoyal Gown, Surgical - DeRoyal Tissue Adhesive for the Topical Approximation of Skin - DeRoyal Snare, Surgical - DeRoyal Catheter, Intravascular, Diagnostic - DeRoyal Camera, Surgical and Accessories - DeRoyal Dilator, Vessel, Surgical - DeRoyal Laryngoscope, Endoscope - DeRoyal Injector and Syringe, Angiographic - DeRoyal Laparoscopy Kit - DeRoyal Sheet, Burn - DeRoyal Transducer, Blood-Pressure, Extravascular - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Laparoscope, General & Plastic Surgery - DeRoyal Catheter and Tip, Suction - DeRoyal Set, Administration, Intravascular - DeRoyal Set, Administration, Intravascular - DeRoyal Instrument, Cranioplasty Material Forming - DeRoyal Connector, Catheter - DeRoyal Suture Kit - DeRoyal Gauze/Sponge, Internal - DeRoyal Introducer, Catheter - DeRoyal Set, administration, intravascular - DeRoyal Set, Administration, Intravascular - DeRoyal Container, Empty, for Collection & Processing of Blood & Blood Components - DeRoyal Suture Removal Kit - DeRoyal Connector, Catheter - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Injector and Syringe, Angiographic - DeRoyal Drape, Surgical - DeRoyal Needle, Hypodermic, Single Lumen - DeRoyal Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) - DeRoyal Drape, Surgical - DeRoyal Speculum, Vaginal, Nonmetal - DeRoyal Laparoscopic Accessories, Gynecologic - DeRoyal Lavage, Jet - DeRoyal Catheter, Intravascular, Therapeutic, Short-Term less than 30 days - DeRoyal Dressing, Wound, Occlusive - DeRoyal Cotton, Roll - DeRoyal Kit, Pelvic Exam - DeRoyal General Surgery Tray (Kit) - DeRoyal General Surgery Tray - DeRoyal Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene - DeRoyal Speculum, Vaginal, Metal - DeRoyal Insufflator, Laparoscopic - DeRoyal Instruments, Surgical, Cardiovascular - DeRoyal Needle, Catheter - DeRoyal Kit, I.V. Start - DeRoyal Clamp, Vascular - DeRoyal Clamp, Surgical, General & Plastic Surgery - DeRoyal Scalpel, One-Piece - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Staple, Implantable - DeRoyal Syringe, Periodontic, Endodontic, Irrigating - DeRoyal Tube, Feeding - DeRoyal Catheter, Retention Type, Balloon - DeRoyal Coagulator, Laparoscopic, Unipolar (and accessories) - DeRoyal Needle, Hypodermic, Single Lumen - DeRoyal Syringe, Piston - DeRoyal Speculum, Vaginal, Nonmetal - DeRoyal System, X-Ray, Fluoroscopic, Image-Intensified - DeRoyal General Purpose Dental Tray - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Protector, Skin Pressure - DeRoyal Syringe, Piston - DeRoyal Depressor, Tongue, Non-Surgical - DeRoyal Cushion, Wheelchair - DeRoyal Suture, Absorbable, Synthetic, Polyglycolic Acid - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Gown, Surgical - DeRoyal Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass - DeRoyal Syringe, Piston - DeRoyal Suture, Nonabsorbable, Silk - DeRoyal Introducer, Catheter - DeRoyal Tube, Aspirating, Flexible, Connecting - DeRoyal Drape, surgical - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Sponge, Ophthalmic - DeRoyal Injector and Syringe, Angiographic - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Surgical Table Cushion - DeRoyal Set, Administration, Intravascular - DeRoyal Suture, Absorbable, Synthetic, Polyglycolic Acid - DeRoyal Kit, Surgical Instrument, Disposable - DeRoyal Applicator, Absorbent Tipped, Sterile - DeRoyal Filter, Bacterial, Breathing - Circuit - DeRoyal Agent, Absorbable Hemostatic, Non-Collagen Based - DeRoyal Collector, Urine, (And Accessories) for Indwelling Catheter - DeRoyal Applier, Surgical, Clip - DeRoyal Forceps, General & Plastic Surgery - DeRoyal Container, I V - DeRoyal Dressing, Wound, Drug - DeRoyal Catheter, Intravascular, Therapeutic, Short-term Less than 30 days - DeRoyal Garment, Protective, for Incontinence - DeRoyal Cesarean Section Kit - DeRoyal Dressing, Wound, Drug - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Stapler, Skin - DeRoyal Wrap, Sterilization - DeRoyal Dissector, Surgical, General & Plastic Surgery - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Culture Media, Non-Selective and Non-Differential - DeRoyal Dressing, Wound, Drug, Lavage, Jet - DeRoyal Catheter, Urethral - DeRoyal Jelly, Lubricating, For Transurethral Surgical Instrument - DeRoyal Pap Smear Kit - DeRoyal MICROSCOPE SLIDES - DeRoyal Bandage, Liquid, Skin Protectant - DeRoyal Thermometer, electronic, clinical - DeRoyal Dressing, Wound, Drug - DeRoyal Set, Administration, Intravascular - DeRoyal Skin Prep Tray (Kit)- DeRoyal Gynecological Laparoscopic Kit - DeRoyal Cystotome - DeRoyal Clip, Implantable - DeRoyal Clip, Implantable - Add Catheter, Urological - DeRoyal Patch, Pledget and Intracardiac, PTTP, PTFE, Polypropylene - DeRoyal Negative Pressure Wound Therapy Powered Suction Pump - DeRoyal Needle, Hypodermic, Single Lumen - DeRoyal Wrap, Sterilization - DeRoyal Wire, Guide, Catheter - DeRoyal Syringe, Irrigating (Non Dental) - DeRoyal Catheter and Tip, Suction - DeRoyal Tourniquet, Nonpneumatic - DeRoyal Syringe, Piston - DeRoyal Marker, Skin - DeRoyal Apparatus, Suction, Operating-Room, Wall Vacuum Powered - DeRoyal Forceps, Ophthalmic - DeRoyal Tubing, Pressure and Accessories - DeRoyal Drape, Surgical - DeRoyal Needle, Hypodermic, Single Lumen - DeRoyal Set, Administration, Intravascular - DeRoyal FZT - Cutter, Surgical - DeRoyal Bag, Urine Collection, Leg, For External Use, Non-Sterile - DeRoyal Transducer, Blood-Pressure, Extravascular - DeRoyal Needle, Aspiration and Injection, Disposable - DeRoyal Dressing, Wound, Drug - Burn, Hydrogel w/Drug and/or Biologic - DeRoyal Suture, Absorbable, Synthetic, Polyglycolic Acid - DeRoyal Saline, Vascular Access Flush - DeRoyal Accessories, Operating-Room, Table (Kit) - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Insufflator, Laparoscopic - DeRoyal Injector and Syringe Angiographic - DeRoyal Laparoscope, General & Plastic Surgery - DeRoyal Catheter, Upper Urinary Tract - DeRoyal Container, Specimen, Sterile - DeRoyal Injector and Syringe, Angiographic - DeRoyal Set, Administration, Intravascular - DeRoyal Suture, Nonabsorbable, Silk - DeRoyal Oxygenator, Cardiopulmonary Bypass - DeRoyal Anesthesia Conduction Kit - Needle, Conduction, Anesthetic (w/wo Introducer) - DeRoyal Tubes, Vials, Systems, Serum Separators, Blood Collection - DeRoyal Suture, Nonabsorbable, Synthetic, Polypropylene - DeRoyal Body Fluid Barrier Kit - DeRoyal Angiography/Angioplasty Kit - DeRoyal Gauze/Sponge, Nonresorbable for External Use - DeRoyal Needle, Conduction, Anesthetic (W/WO Introducer)- DeRoyal BLOOD PRESSURE CUFF - DeRoyal Device, Occlusion, Umbilical - DeRoyal Hysterectomy Kit - DeRoyal Stethoscope, Esophageal, with Electrical Conductors - DeRoyal Dressing Change Tray - DeRoyal Electrosurgical Cutting & Coagulation Accessories - DeRoyal Condom - DeRoyal Gauze/Sponge, Internal - DeRoyal Syringe, balloon inflation - DeRoyal Stopcock, IV Set - DeRoyal Suture, Absorbable, Synthetic - DeRoyal Set, Administration, Intravascular - DeRoyal Syringe, Piston - DeRoyal Catheter, Urological (antimicrobial) and Accessories - DeRoyal Cover, Barrier, Protective - DeRoyal Polymer Patient Examination Glove - DeRoyal Catheter, Urological - DeRoyal Collector, Urine, (and Accessories) for Indwell Cath/ Tray, Catheteriz, Sterile Urethral, w/wo Catheter (kit)- DeRoyal Cannula, surgical, General & Plastic Surgery - DeRoyal Tubing, Fluid Delivery - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Pad, Eye - DeRoyal Laparoscope, General & Plastic Surgery - DeRoyal Dressing, Wound, Drug - DeRoyal Electrocautery, Gynecologic (and Accessories) - DeRoyal Set, Administration, Intravascular - DeRoyal Catheter, Intravascular, Therapeutic, Short-term less than 30 days - DeRoyal Handle, Scalpel - DeRoyal Unit, Suction Operatory - DeRoyal Medical Glove, Specialty - DeRoyal Accessory, Surgical Apparel - DeRoyal Labor and Delivery Kit - DeRoyal Pad, Alcohol, Device Disinfectant - DeRoyal Catheter, Cannula and Tubing, Vascular, Cardiopulmonary bypass - DeRoyal Wrap, Sterilization - DeRoyal Electrocautery, Gynecologic (and Accessories) - DeRoyal Catheter, Urological - DeRoyal Suture, Surgical, Absorbable, Polydioxanone - DeRoyal Holder, Needle; Orthopedic - DeRoyal Table, Cystometric, Electric - DeRoyal Catheter, Intravascular, Diagnostic - DeRoyal Aspiration Tray (Kit) - DeRoyal Gauze/Sponge, Internal, X-Ray Detectable - DeRoyal Gown, Surgical - DeRoyal Accessories, Cleaning Brushes, for Endoscope - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal DEROYAL THERMO-COLD S Pack, Hot and Cold, Disposable - DeRoyal Tubing/Tubing with Filter, Insufflation, Laparoscopic - DeRoyal Gastroenterology - Urology - DeRoyal Tubing, Noninvasive - DeRoyal System, Imaging, Pulsed Echo, Ultrasonic - DeRoyal Shield, Eye, Ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) - DeRoyal Forceps - DeRoyal Dilator, Vessel, for Percutaneous Catheterization - DeRoyal Absorber, Saliva, Paper - DeRoyal Drape, Surgical - DeRoyal Laparoscope, General & Plastic Surgery - DeRoyal Injector and Syringe, Angiographic - DeRoyal Blade, Saw, General & Plastic Surgery, Surgical - DeRoyal HRX Arthroscope GEI Electrosurgical, Cutting & coagulation & Accessories - DeRoyal Bandage, Cast - DeRoyal Catheter, Intravascular, Therapeutic, short-term less than 30 days - DeRoyal Lift, Patient, Non-AC-Powered - DeRoyal Wax, Bone - DeRoyal Needle, Hypodermic, Single Lumen - DeRoyal Drape, Surgical - DeRoyal Halter, Head, Traction - DeRoyal Laparoscope, General & Plastic Surgery - DeRoyal Catheter, Cannula and Tubing, Vascular, Cardiopulmonary bypass - DeRoyal Tape and Bandage, Adhesive - DeRoyal Vinyl Patient Examination Glove - DeRoyal Tray, Surgical, Instrument - DeRoyal Stocking, Elastic - DeRoyal Set, Administration, Intravascular - DeRoyal System, irrigation, Urological - DeRoyal Trephine, Manual, Ophthalmic - DeRoyal Set, Administration, Intravascular - DeRoyal Syringe, Piston - DeRoyal System, X-Ray, Angiographic - DeRoyal Neurosurgical Paddie - DeRoyal Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene - DeRoyal Foley Catheter Kit (excludes HIV testing) - DeRoyal Blood and Urine Collection Kit (Excludes HIV Testing) - DeRoyal Staple, Removeable (Skin) - DeRoyal General surgery tray - DeRoyal Lubricant, Patient - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Holder, Needle, Gastroenterologic - DeRoyal Applicator, Absorbent Tipped, Non-Sterile - DeRoyal Pad, Menstrual, Unscented - DeRoyal Laparoscope, General & Plastic Surgery - DeRoyal Suture, Nonabsorbable, Synthetic, Polypropylene - DeRoyal Syringe Piston - DeRoyal Catheter, Continuous Irrigation - DeRoyal Stopcock, IV Set - DeRoyal Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Gown, Surgical - DeRoyal Pneumoperitoneum Needle - DeRoyal Syringe, Piston - DeRoyal Syringe, Piston - DeRoyal Medical Glove, Specialty - DeRoyal Dressing, Wound and Burn, Occlusive - DeRoyal Suture, Nonabsorbable, Silk - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Wire, Guide, Catheter - DeRoyal Needle, Suturing, Disposable - DeRoyal Cardiovascular Procedure Kit - DeRoyal Tissue Adhesive for the Topical Approximation of Skin - DeRoyal Transducer, Blood-Pressure, Extravascular - DeRoyal Joint, Elbow, External Limb Component, Mechanical - DeRoyal Sampler, Amniotic Fluid (Amniocentesis Tray) - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Bag, Intestine - DeRoyal Grounding Pad Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Bandage, Liquid - DeRoyal Clip, Vascular - DeRoyal Apparatus, Suction, Single Patient Use, Portable, Nonpowered - DeRoyal Thermometer, Electronic, Clinical - DeRoyal

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2015-11-09
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-04-10
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2014-08-01
FAM	Sigmoidoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2012-09-26
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-05-29
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2005-04-20
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2006-08-09
FXY	Hood, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-05-29
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2001-11-28
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2023-04-19
EMD	Hemostat, Surgical	Dental	Class 1	872.4565	2024-05-02
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2024-12-13
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2015-11-09
BYZ	Trap, Sterile Specimen	General Hospital	Class 2	880.6740	2025-04-23
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2024-12-13
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2024-05-24
KCH	Hook, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2024-06-06
EYC	Catheter, Upper Urinary Tract	Gastroenterology, Urology	Class 2	876.5130	2012-09-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-12-30
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2001-02-06
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2024-05-24
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2025-02-18
DRI	Monitor, Line Isolation	Cardiovascular	Class 1	870.2620	2025-01-02
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2015-09-22
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2025-06-11
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2016-07-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-12-27
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-05-23
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-12-13
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-05-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2009-12-28
LYV	Label Or Tag, Sterile	General, Plastic Surgery	Class 1	878.4800	2005-02-24
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	1998-08-19
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2024-01-16
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2022-08-15
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-08-01
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2005-08-25
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2024-05-23
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-05-23
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-09-25
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2025-12-02
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2022-08-17
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2025-01-28
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-05-29
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-06-03
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	General, Plastic Surgery	Class 2	878.4780	2025-05-14
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2012-09-04
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2004-12-09
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2024-12-13
MTJ	Wax, Bone	Unknown	Class U	N/A	2016-02-08
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-01-27
PWU	Clean-Up Kit	General Hospital	Class 1	880.6890	2021-08-11
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-01-12
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
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2004-06-23
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2025-06-09
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2024-12-13
HXB	Probe	Orthopedic	Class 1	888.4540	2026-01-13
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2024-01-02
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	1998-08-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-12-30
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-06-06
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2001-08-03
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2005-06-23
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2015-11-10
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2024-12-13
OGR	Ear, Nose, And Throat Surgical Tray	Ear, Nose, Throat	Class 1	874.4420	2016-09-22
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2005-04-14
OJK	Eye Tray	Ophthalmic	Class 2	886.4790	2017-07-31
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-01-27
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2015-09-17
OFA	Cardiovascular Surgical Instruments Tray	Cardiovascular	Class 1	870.4500	2021-05-24
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-11-01
MPN	Tissue Adhesive For The Topical Approximation Of Skin	General, Plastic Surgery	Class 2	878.4010	2025-05-30
GAE	Snare, Surgical	General, Plastic Surgery	Class 1	878.4800	2005-09-28
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2008-12-17
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	1997-02-12
DWP	Dilator, Vessel, Surgical	Cardiovascular	Class 2	870.4475	2025-04-08
GCI	Laryngoscope, Endoscope	Gastroenterology, Urology	Class 2	876.1500	2025-01-20
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2017-11-01
FDE	Laparoscopy Kit	Gastroenterology, Urology	Class 2	876.1500	2016-03-07
FPY	Sheet, Burn	General Hospital	Class 1	880.5180	2004-12-09
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2025-08-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-05-24
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2009-08-24
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2012-09-20
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-06-10
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-08-26
HBX	Instrument, Cranioplasty Material Forming	Neurology	Class 1	882.4500	2024-11-12
GCD	Connector, Catheter	General, Plastic Surgery	Class 1	878.4200	2024-05-24
OVN	Suture Kit	General, Plastic Surgery	Class 2	878.4830	2016-02-08
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-12-13
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2012-08-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-19
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-06-04
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	Class 2	864.9100	2009-12-30
MCZ	Suture Removal Kit	General, Plastic Surgery	Class 1	878.4800	2015-12-10
GCD	Connector, Catheter	General, Plastic Surgery	Class 1	878.4200	2012-09-25
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-09-05
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2025-03-12
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2013-09-05
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-01-14
KNF	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)	Obstetrics/Gynecology	Class 2	884.4160	2024-04-25
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2024-05-24
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2015-09-17
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2012-11-02
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2011-12-30
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2024-08-27
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2004-12-09
EFN	Cotton, Roll	Dental	Class 1	872.6050	2004-10-15
MLT	Pelvic Exam Kit	Obstetrics/Gynecology	Class 2	884.4530	2016-05-17
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2016-06-03
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2024-02-19
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2024-05-24
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2013-05-22
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2012-08-28
GCB	Needle, Catheter	General, Plastic Surgery	Class 1	878.4200	2012-02-28
LRS	I.V. Start Kit	General Hospital	Class 2	880.5200	2015-12-10
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2011-05-05
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-07-23
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2006-08-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-05-23
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2024-05-23
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2017-07-17
FPD	Tube, Feeding	Gastroenterology, Urology	Class 2	876.5980	2012-11-16
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2012-09-28
HFG	Coagulator, Laparoscopic, Unipolar (And Accessories)	Obstetrics/Gynecology	Class 2	884.4160	2024-12-13
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-12-24
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-01-14
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2024-05-23
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2012-09-04
OFX	General Purpose Dental Tray	Dental	Class 1	872.6640	2024-01-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-05-11
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2006-07-27
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-01-14
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2001-08-03
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	1999-05-21
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	2016-01-26
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2014-02-10
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2013-12-24
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-01-14
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2013-08-26
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-01-20
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2004-11-03
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2017-02-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-12-13
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2024-12-04
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2017-11-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-09-05
LWG	Surgical Table Cushion	General, Plastic Surgery	Class 1	878.4950	2006-07-27
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-05-23
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2024-01-18
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2001-08-03
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2004-06-23
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2017-11-14
LMG	Agent, Absorbable Hemostatic, Non-Collagen Based	General, Plastic Surgery	Class 3	878.4490	2022-08-17
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2024-05-24
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2024-01-18
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2001-08-03
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2024-05-29
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2015-11-06
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2024-05-24
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2016-01-13
OHM	Cesarean Section Tray	Obstetrics/Gynecology	Class 2	884.1720	2016-03-07
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2016-07-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-01-23
QQS	Stapler, Skin	General Hospital	Class 1	878.4740	2022-04-06
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2024-01-08
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2001-08-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-12-04
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-04-10
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	Class 1	866.2300	2020-07-14
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2025-07-17
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2025-07-17
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2021-11-04
FHX	Jelly, Lubricating, For Transurethral Surgical Instrument	Gastroenterology, Urology	Class 2	876.1500	2011-06-28
OHL	Pap Smear Kit	Obstetrics/Gynecology	Class 2	884.4530	2016-03-07
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2004-07-12
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
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2025-01-20
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-12-13
OJU	Skin Prep Tray	General, Plastic Surgery	Class 1	878.4800	2016-03-07
OHD	Gynecological Laparoscopic Kit	Obstetrics/Gynecology	Class 2	884.1720	2016-03-07
HNY	Cystotome	Ophthalmic	Class 1	886.4350	2016-01-27
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2024-01-18
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
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2024-12-13
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2022-08-15
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2025-12-02
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2025-02-18
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2022-06-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-06-06
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	1997-10-23
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2024-12-13
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2005-09-28
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-01-14
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2006-08-22
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2013-02-15
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-08-14
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2004-11-03
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2013-08-26
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
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2015-11-09
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2017-04-19
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2012-09-28
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2012-09-04
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2005-05-12
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	Unknown	Class U	N/A	2021-07-21
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2021-07-21
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2024-05-23
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2024-01-16
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2012-09-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-01-27
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
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2022-06-28
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-12-13
EYC	Catheter, Upper Urinary Tract	Gastroenterology, Urology	Class 2	876.5130	2020-11-19
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2004-03-03
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2007-12-19
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
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
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2012-12-28
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
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2012-09-17
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2024-08-08
OKH	Body Fluids Barrier Kit	General, Plastic Surgery	Class 2	878.4040	2016-02-08
OEQ	Angiography/Angioplasty Kit	Cardiovascular	Class 2	870.1650	2016-03-07
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	1994-01-04
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2016-01-13
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2006-06-20
FOD	Device, Occlusion, Umbilical	General Hospital	Class 1	880.5950	1997-02-12
OJF	Hysterectomy Kit	Obstetrics/Gynecology	Class 2	884.4530	2016-05-17
BZT	Stethoscope, Esophageal, With Electrical Conductors	Anesthesiology	Class 2	868.1920	2016-10-24
OXQ	Dressing Change Tray	General Hospital	Class 1	880.5075	2015-12-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-11-15
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2012-09-17
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2012-09-21
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2012-10-24
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2017-11-01
GAN	Suture, Absorbable, Synthetic	General, Plastic Surgery	Class 2	878.4830	2024-01-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-05-22
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-01-14
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
MMP	Cover, Barrier, Protective	General, Plastic Surgery	Class 2	878.4370	2011-09-19
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-05-23
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2023-09-29
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
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-10-24
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2024-05-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-10-18
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2016-01-27
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2015-11-09
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-07-23
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2013-01-24
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-08-26
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2016-01-14
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2012-09-17
EBR	Unit, Suction Operatory	Dental	Class 1	872.6640	2016-01-13
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
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2005-08-25
MLS	Labor And Delivery Kit	Obstetrics/Gynecology	Class 2	884.4530	2016-03-07
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2016-02-08
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2024-09-10
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2024-05-15
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2012-11-02
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2012-09-17
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2024-08-26
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2024-07-31
MMZ	Table, Cystometric, Electric	Gastroenterology, Urology	Class 2	876.4890	2024-10-17
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2024-05-24
OJT	Aspiration Tray	General, Plastic Surgery	Class 1	878.4800	2016-05-17
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2006-08-22
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-05-29
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2016-02-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-12-30
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2006-08-09
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2009-08-21
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2024-05-23
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2024-12-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-02-08
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2012-09-25
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2006-08-22
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2012-09-04
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2023-11-14
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2014-02-10
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-01-08
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2016-03-30
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2005-06-23
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
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2005-08-08
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2022-07-25
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2024-12-13
MTJ	Wax, Bone	Unknown	Class U	N/A	2024-05-24
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-01-14
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2024-05-23
HSS	Halter, Head, Traction	Orthopedic	Class 1	888.5890	2006-08-09
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2012-05-23
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2024-12-13
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2003-04-04
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2024-01-12
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2001-05-16
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2015-09-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-08-26
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2024-12-13
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2024-12-13
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-07-18
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-12-13
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2012-09-04
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2012-09-04
HBA	Neurosurgical Paddie	Neurology	Class 2	882.4700	2016-01-27
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2022-08-15
PPB	Foley Catheter Kit (Excludes Hiv Testing)	Gastroenterology, Urology	Class 2	876.5130	2018-01-02
OIB	Blood And Urine Collection Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2016-05-17
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2024-05-24
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2016-03-07
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2024-06-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-05-23
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
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2012-09-25
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-05-23
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2016-01-15
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-01-14
GBQ	Catheter, Continuous Irrigation	General, Plastic Surgery	Class 1	878.4200	2015-11-09
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2024-05-23
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2024-02-27
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-12
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-05-30
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2016-06-22
FHO	Pneumoperitoneum Needle	Gastroenterology, Urology	Class 2	876.1500	2016-06-22
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-07-18
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-05-19
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
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-12-13
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2024-12-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-03-13
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2015-11-09
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	1997-11-12
OEZ	Cardiovascular Procedure Kit	Cardiovascular	Class 2	870.1200	2022-08-30
MPN	Tissue Adhesive For The Topical Approximation Of Skin	General, Plastic Surgery	Class 2	878.4010	2022-08-15
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2025-08-26
IRD	Joint, Elbow, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	2016-08-31
HIO	Sampler, Amniotic Fluid (Amniocentesis Tray)	Obstetrics/Gynecology	Class 1	884.1550	2016-11-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-01-27
KGY	Bag, Intestine	General, Plastic Surgery	Class 1	878.4100	2012-11-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2011-01-05
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2024-06-25
DSS	Clip, Vascular	Cardiovascular	Class 2	870.3250	2025-04-10
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2024-12-13
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-09-22

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
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06
K910084	Biocor Medical, Inc.	SURGICAL DRAPE	1991-03-19
K791969	Medline Industries, Inc.	DYNACOR STERILE CLOSED SYS. DRAINAGE BAG	1979-11-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-06	VIASYS Med Systems	2	Stackhouse FreedomAire Lens/Hood; a sterile disposable protective head garment for use with the FreedomAire Surgical Helmet System, providing a clear plastic bubble lens and protective head hood to connect to the surgical helmet; individually packaged hoods, 12 per case; Manufactured for Viasys MedSystems, Wheeling, IL 60090
Z-0002-06	VIASYS Med Systems	2	Stackhouse Lens/Hood, Mark III Universal; a sterile disposable protective head garment for use with the Stackhouse Mark III Helmet, providing a clear plastic bubble lens and protective head hood to connect to the surgical helmet; individually packaged hoods, 12 per case; Manufactured for Viasys MedSystems, Wheeling, IL 60090
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes

Similar Registrations

Registration Number	Establishment Name	Location
1531062	E-BEAM SERVICES, INC.	LEBANON, OH, US
9680515	TONTARRA MEDIZINTECHNIK GMBH	WURMLINGEN Baden-Wurttemberg, DE
2950160	WRIGHT ENGINEERED PLASTICS, INC.	Santa Rosa, CA, US
3005809810	Jarit GmbH	Rietheim-Weilheim Baden-Wurttemberg, DE
2030624	Isomedix Operations, Inc.	Temecula, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1055236. Last updated year: 2026. Please use registration number 1055236 when referencing this establishment in official correspondence.