FDA product codes
The device classification tree, in product code order.
FDA classifies every device type under a three-letter product code, and that code is what ties a clearance to a recall to a registered listing. Each page here carries the FDA definition, the regulation it sits under, clearance volume by year, and the companies that list the code with FDA.
Data as of , the FDA export date. FDA product classification database
Review panels
6,880 codes| Review panel | Panel code | Product codes |
|---|---|---|
| Anesthesiology | AN | 262 |
| Cardiovascular | CV | 437 |
| Clinical Chemistry | CH | 527 |
| Clinical Toxicology | TX | 338 |
| Dental | DE | 352 |
| Ear, Nose, Throat | EN | 269 |
| Gastroenterology, Urology | GU | 614 |
| General Hospital | HO | 394 |
| General, Plastic Surgery | SU | 562 |
| Hematology | HE | 281 |
| Immunology | IM | 278 |
| Medical Genetics | MG | 7 |
| Microbiology | MI | 554 |
| Neurology | NE | 291 |
| Obstetrics/Gynecology | OB | 269 |
| Ophthalmic | OP | 345 |
| Orthopedic | OR | 349 |
| Pathology | PA | 325 |
| Physical Medicine | PM | 210 |
| Radiology | RA | 216 |
| Code | Device name | Class | Regulation | Clearances | Recalls |
|---|---|---|---|---|---|
| NQX | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | Class II | 21 CFR 866.1640 | 24 | 20 |
| NQY | Ventilator, Continuous, Minimal Ventilatory Support, Home Use | Class II | 21 CFR 868.5895 | 0 | 0 |
| NQZ | Antigen, Invasive Fungal Pathogens | Class II | 21 CFR 866.3050 | 2 | 2 |
| NRA | Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing | Class III | 0 | 32 | |
| NRB | Wound Cleaner, Ultrasound | Class II | 21 CFR 878.4410 | 9 | 0 |
| NRC | Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile | Class I | 21 CFR 884.5425 | 0 | 0 |
| NRD | Unit, Operative Dental, Accessories | Class I | 21 CFR 872.6640 | 2 | 0 |
| NRF | Material, Quality Control, Semen Analysis | Class II | 21 CFR 864.8625 | 3 | 1 |
| NRH | System, Breath Measurement | Class I | 21 CFR 862.1820 | 4 | 3 |
| NRI | Autoantibodies, Nuclear Pore Glycoprotein Gp210 | Class II | 21 CFR 866.5090 | 2 | 0 |
| NRJ | Ultrasound, Skin Permeation | Class II | 21 CFR 878.4410 | 1 | 0 |
| NRK | Kit, Test, Olfactory | Class II | 21 CFR 874.1600 | 1 | 0 |
| NRL | Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis | Class II | 21 CFR 866.3045 | 1 | 0 |
| NRN | Leeches, Medicinal | Unclassified | 3 | 0 | |
| NRP | Sirolimus Test System | Class II | 21 CFR 862.3840 | 5 | 6 |
| NRQ | Blade-Form Endosseous Dental Implant | Class II | 21 CFR 872.3640 | 5 | 0 |
| NRS | Control Material, Blood Circulating Epithelial Cancer Cell | Class II | 21 CFR 864.8625 | 1 | 1 |
| NRU | Chair, Dental, Without Operative Unit | Class I | 21 CFR 872.6250 | 0 | 4 |
| NRV | Implantable Radio Frequency Transponder System | Class II | 21 CFR 880.6300 | 1 | 0 |
| NRW | Stimulator, Intramuscular, Automatic | Class II | 21 CFR 880.5580 | 1 | 0 |
| NRX | Complement 4d (C4d) And Complement Receptor 1 (Cr1) | Class II | 21 CFR 866.5820 | 0 | 0 |
| NRY | Catheter, Thrombus Retriever | Class II | 21 CFR 870.1250 | 115 | 27 |
| NRZ | Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided | Class III | 0 | 0 | |
| NSA | Over-The-Counter Automated External Defibrillator | Class III | 21 CFR 870.5310 | 1 | 2 |
| NSB | Patient Personal Hygiene Kit | Class I | 21 CFR 872.6855 | 0 | 16 |
| NSC | Injector, Pen | Class II | 21 CFR 880.5860 | 1 | 0 |
| NSD | Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence | Class III | 0 | 0 | |
| NSF | Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment | Class II | 21 CFR 866.6030 | 2 | 1 |
| NSI | System, Imaging, Esophageal, Wireless, Capsule | Class II | 21 CFR 876.1300 | 7 | 0 |
| NSJ | Restoration, Noble Metal | Not classified | 0 | 0 | |
| NSK | Dentures, Partial | Not classified | 0 | 0 | |
| NSL | Dentures, Full | Not classified | 0 | 0 | |
| NSM | Restoration, Resin | Not classified | 0 | 0 | |
| NSN | Restoration, Resin, Crown And Bridge | Not classified | 0 | 0 | |
| NSO | Restoration, Porcelain-Fused-To-Metal | Not classified | 0 | 0 | |
| NSP | Restoration, Porcelain | Not classified | 0 | 1 | |
| NSQ | Restoration, Base Metal | Not classified | 0 | 1 | |
| NSR | Prosthesis, Orthodontic | Not classified | 0 | 1 | |
| NSS | Electronic Media, Nausea | Not classified | 0 | 0 | |
| NST | Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking | Class II | 21 CFR 866.5660 | 4 | 0 |
| NSU | Instrumentation For Clinical Multiplex Test Systems | Class II | 21 CFR 862.2570 | 13 | 14 |
| NTB | System, Ablation, Ultrasound And Accessories | Class II | 21 CFR 878.4400 | 6 | 0 |
| NTC | Nursing Pad, Hydrogel | Class I | 21 CFR 880.5630 | 1 | 0 |
| NTE | Temporary Carotid Catheter For Embolic Capture | Class II | 21 CFR 870.1250 | 36 | 30 |
| NTG | Prosthesis, Ankle, Uncemented, Non-Constrained | Class III | 0 | 4 | |
| NTH | System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays | Class II | 21 CFR 866.4700 | 8 | 0 |
| NTI | Drug Metabolizing Enzyme Genotyping Systems | Class II | 21 CFR 862.3360 | 11 | 4 |
| NTK | Light Transmission Caries Detector | Class II | 21 CFR 872.1745 | 12 | 0 |
| NTM | Antigen, Inflammatory Response Marker, Sepsis | Class II | 21 CFR 866.3210 | 3 | 2 |
| NTN | Led Light Source | Class II | 21 CFR 876.1500 | 9 | 0 |
| NTO | Rinse, Oral, Antibacterial (By Physical Means) | Class II | 21 CFR 872.5580 | 2 | 2 |
| NTR | Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells | Class I | 21 CFR 864.1860 | 1 | 1 |
| NTU | Evoked Potential Stimulator, Thermal | Class II | 21 CFR 882.1870 | 3 | 0 |
| NTV | Myeloperoxidase, Immunoassay, System, Test | Class II | 21 CFR 866.5600 | 2 | 1 |
| NTW | System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test | Class II | 21 CFR 866.4070 | 2 | 1 |
| NTX | Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) | Class I | 21 CFR 880.5630 | 1 | 0 |
| NTY | System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer | Class II | 21 CFR 866.6010 | 1 | 0 |
| NTZ | Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator | Class II | 21 CFR 876.5820 | 1 | 0 |
| NUA | System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection | Class II | 21 CFR 866.5900 | 12 | 2 |
| NUB | Colonic Irrigation System, General Well Being | Class III | 21 CFR 876.5220 | 0 | 0 |
| NUC | Lubricant, Personal | Class II | 21 CFR 884.5300 | 249 | 7 |
| NUD | Vertebroplasty Compound, Calcium Based | Class II | 21 CFR 888.3027 | 0 | 0 |
| NUF | Catheter, Neurovasculature, Occluding Balloon | Class III | 21 CFR 882.5150 | 0 | 0 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | Class II | 21 CFR 882.5890 | 230 | 0 |
| NUI | Ultrasound, Infusion, System | Class II | 21 CFR 870.1200 | 4 | 0 |
| NUJ | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | Class II | 21 CFR 878.4400 | 37 | 20 |
| NUK | For Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test System | Not classified | 0 | 1 | |
| NUL | For Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test System | Not classified | 0 | 0 | |
| NUM | Autoantibodies, Nuclear Body Protein, Sp100 | Class II | 21 CFR 866.5090 | 1 | 0 |
| NUN | Bone Grafting Material, Human Source | Class II | 21 CFR 872.3930 | 15 | 0 |
| NUP | Cream, Nasal, Topical, Mechanical Allergen Particle Barrier | Class II | 21 CFR 880.5045 | 8 | 0 |
| NUQ | Pad, Menstrual, Reusable | Class I | 21 CFR 884.5435 | 1 | 0 |
| NUR | Pad, Menstrual, Intralabial | Class I | 21 CFR 884.5435 | 0 | 0 |
| NUU | Lens, Contact, Orthokeratology, Overnight | Class III | 21 CFR 886.5916 | 0 | 2 |
| NUV | Massager, Vacuum, Light Induced Heating | Class II | 21 CFR 878.4810 | 20 | 0 |
| NUW | Stimulator, Muscle, Powered, Dental | Class II | 21 CFR 890.5850 | 9 | 0 |
| NUX | Cleanser, Denture, Prescription | Class I | 21 CFR 872.3520 | 0 | 0 |
| NVA | Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Mesothelioma | Class II | 21 CFR 866.6010 | 0 | 0 |
| NVB | Intraocular, Pressure Measuring Device | Class III | 21 CFR 886.4280 | 0 | 0 |
| NVC | Bone, Heterograft | Class III | 21 CFR 888.3015 | 0 | 0 |
| NVE | Washer, Cleaner, Automated, Endoscope | Class II | 21 CFR 876.1500 | 12 | 1 |
| NVG | Tissue Culture, Accessories, Dental | Class I | 21 CFR 864.2240 | 0 | 0 |
| NVH | Suture, Knot, Mechanical | Class II | 21 CFR 878.4300 | 1 | 0 |
| NVI | Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease | Class II | 21 CFR 862.3100 | 1 | 1 |
| NVJ | Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women | Class II | 21 CFR 878.4400 | 1 | 1 |
| NVK | Laser, Dental, Soft Tissue | Class II | 21 CFR 878.4810 | 17 | 2 |
| NVM | Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon | Class II | 21 CFR 870.1250 | 5 | 2 |
| NVN | Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes | Class III | 0 | 0 | |
| NVO | Spacer, Direct Patient Interface | Class II | 21 CFR 868.5630 | 2 | 0 |
| NVP | Holding Chambers, Direct Patient Interface | Class II | 21 CFR 868.5630 | 16 | 3 |
| NVQ | Bacteriophage And Controls, B. Anthracis Lysis | Class II | 21 CFR 866.3045 | 2 | 1 |
| NVR | Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar | Class III | 6 | 17 | |
| NVT | Tubing And Tubing/Filter Fits | Class I | 21 CFR 884.1700 | 0 | 1 |
| NVV | Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System | Class I | 21 CFR 862.2100 | 0 | 0 |
| NVY | Permanent Defibrillator Electrodes | Class III | 0 | 5 | |
| NVZ | Pulse Generator, Permanent, Implantable | Class III | 0 | 40 | |
| NWA | Prosthesis, Tracheal, Preformed/Molded | Class II | 21 CFR 878.3720 | 7 | 0 |
| NWB | Endoscope, Accessories, Narrow Band Spectrum | Class II | 21 CFR 876.1500 | 9 | 19 |
| NWE | Colon Computed Tomography System, Computer Aided Detection | Class II | 21 CFR 892.2050 | 4 | 0 |
| NWF | Drill, Battery Powered, Subungual Hematoma | Class I | 21 CFR 878.4820 | 1 | 0 |
