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 |
|---|---|---|---|---|---|
| NCO | Implant, Cartilage, For Articular Cartilage Repair | Class III | 0 | 0 | |
| NCR | Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered | Class II | 21 CFR 886.4100 | 3 | 1 |
| NCS | System, Imaging, Holography, Acoustic | Class II | 21 CFR 892.1550 | 3 | 0 |
| NCT | Instrument, Glucose, Noninvasive Technology | Class III | 0 | 0 | |
| NCV | Lithotripter, Shockwave (For Treating Gallbladder Stones) | Class III | 0 | 0 | |
| NCW | System, Test, Her-2/Neu, Monitoring | Class II | 21 CFR 866.6010 | 3 | 1 |
| NCX | System, Hypothermia, Intravenous, Cooling | Class II | 21 CFR 870.5900 | 26 | 35 |
| NCZ | Lens, Contact, For Color Vision Deficiency | Class II | 21 CFR 886.5925 | 1 | 0 |
| NDA | Helmet, Cranial, For Protective Use | Class I | 21 CFR 890.3025 | 0 | 1 |
| NDC | Calculator, Drug Dose | Class II | 21 CFR 868.1890 | 55 | 13 |
| NDD | Cerclage, Fixation, Metallic | Class II | 21 CFR 888.3010 | 1 | 0 |
| NDE | Rod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible | Class II | 21 CFR 888.3020 | 0 | 1 |
| NDF | Plate, Fixation, Bone, Non-Spinal, Metallic | Class II | 21 CFR 888.3030 | 3 | 1 |
| NDG | Washer, Bolt, Nut, Non-Spinal, Metallic | Class II | 21 CFR 888.3030 | 1 | 1 |
| NDH | Nail, Fixation, Bone, Metallic | Class II | 21 CFR 888.3030 | 0 | 3 |
| NDI | Staple, Fixation, Bone, Metallic | Class II | 21 CFR 888.3030 | 0 | 0 |
| NDJ | Screw, Fixation, Bone, Non-Spinal, Metallic | Class II | 21 CFR 888.3040 | 0 | 13 |
| NDK | System, External Fixator (With Metallic Invasive Components) | Class II | 21 CFR 888.3040 | 3 | 0 |
| NDL | Pin, Fixation, Smooth, Metallic | Class II | 21 CFR 888.3040 | 2 | 1 |
| NDM | Pin, Fixation, Threaded, Metallic | Class II | 21 CFR 888.3040 | 1 | 0 |
| NDN | Cement, Bone, Vertebroplasty | Class II | 21 CFR 888.3027 | 108 | 86 |
| NDP | Accessories, Implant, Dental, Endosseous | Class I | 21 CFR 872.3980 | 4 | 57 |
| NDQ | System, Catheter Or Guidewire, Steerable (Magnetic) | Class II | 21 CFR 870.1290 | 2 | 0 |
| NDR | Enzyme Immunoassay, Inhibin-A | Class I | 21 CFR 862.1260 | 1 | 3 |
| NDS | Media, Culture, Ex Vivo, Tissue And Cell | Class II | 21 CFR 876.5885 | 9 | 7 |
| NDV | Test, Ecarin Clotting Time (Ect) | Humanitarian device exemption | 0 | 0 | |
| NDW | Assay, Porphyrin, Spectrophotometry, Lithium | Class II | 21 CFR 862.3560 | 7 | 7 |
| NDY | Test, Cystatin C | Class II | 21 CFR 862.1225 | 22 | 4 |
| NDZ | Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis | Class I | 21 CFR 866.3370 | 1 | 1 |
| NEA | Cement, Ear, Nose And Throat | Class II | 21 CFR 872.3275 | 6 | 0 |
| NEC | Bandage, Liquid, Skin Protectant | Class I | 21 CFR 880.5090 | 3 | 6 |
| NEG | Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis | Class III | 0 | 2 | |
| NEH | Anchor, Fascial | Class II | 21 CFR 878.4300 | 1 | 0 |
| NEI | Prosthesis, Condyle, Mandibular, Temporary | Class II | 21 CFR 872.4770 | 7 | 0 |
| NEJ | System, Cryosurgical, Liquid Nitrogen, For Gastroenterology | Class II | 21 CFR 878.4350 | 0 | 0 |
| NEK | Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction | Class III | 0 | 8 | |
| NEO | System, Test, Osteocalcin | Class II | 21 CFR 862.1050 | 2 | 2 |
| NEP | System/Device, Pharmacy Compounding | Class II | 21 CFR 880.5440 | 0 | 41 |
| NEQ | Device, Telemedicine, Robotic | Class II | 21 CFR 876.1500 | 2 | 0 |
| NEU | Marker, Radiographic, Implantable | Class II | 21 CFR 878.4300 | 110 | 14 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | Class II | 21 CFR 878.4840 | 67 | 40 |
| NEY | System, Ablation, Microwave And Accessories | Class II | 21 CFR 878.4400 | 68 | 27 |
| NEZ | System, Imaging, Gastrointestinal, Wireless, Capsule | Class II | 21 CFR 876.1300 | 47 | 6 |
| NFA | Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection | Class II | 21 CFR 870.1250 | 22 | 4 |
| NFB | Conserver, Oxygen | Class II | 21 CFR 868.5905 | 71 | 6 |
| NFD | Selector, Color, Spectacle, Lens, Tint | Class I | 21 CFR 886.1160 | 1 | 0 |
| NFE | Materials, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Alveolar Ridge Augmentation | Class II | 21 CFR 872.3680 | 0 | 0 |
| NFF | Device, Storage, Images, Ophthalmic | Class I | 21 CFR 892.2010 | 1 | 1 |
| NFG | Device, Communications, Images, Ophthalmic | Class I | 21 CFR 892.2020 | 0 | 1 |
| NFH | Digitizer, Images, Ophthalmic | Class II | 21 CFR 892.2030 | 0 | 0 |
| NFI | Device, Hardcopy, Images, Ophthalmic | Class II | 21 CFR 892.2040 | 0 | 0 |
| NFJ | System, Image Management, Ophthalmic | Class II | 21 CFR 892.2050 | 53 | 14 |
| NFK | Kit, Repair, Catheter, Hemodialysis | Class II | 21 CFR 876.5540 | 11 | 12 |
| NFM | Expander, Tissue, Orbital | Class II | 21 CFR 886.3320 | 2 | 0 |
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | Class II | 21 CFR 882.5890 | 82 | 2 |
| NFP | Device, Dental Sonography, For Diagnosis Of Tmj / Mpd Disorders | Class II | 21 CFR 872.2050 | 0 | 0 |
| NFQ | Device, Dental Sonography, For Monitoring Jaw Sounds | Class I | 21 CFR 872.2050 | 4 | 0 |
| NFR | Device, Jaw Tracking, For Diagnosis Of Tmj / Mpd Disorders | Class II | 21 CFR 872.2060 | 0 | 0 |
| NFS | Device, Jaw Tracking, For Monitoring Jaw Positions | Class I | 21 CFR 872.2060 | 2 | 0 |
| NFT | Test, Amphetamine, Over The Counter | Class II | 21 CFR 862.3100 | 32 | 0 |
| NFV | Test, Benzodiazepine, Over The Counter | Class II | 21 CFR 862.3170 | 0 | 0 |
| NFW | Test, Cannabinoid, Over The Counter | Class II | 21 CFR 862.3870 | 4 | 0 |
| NFX | Test, Cholesterol, Total, Over The Counter | Class I | 21 CFR 862.1175 | 1 | 0 |
| NFY | Test, Cocaine And Cocaine Metabolites, Over The Counter | Class II | 21 CFR 862.3250 | 0 | 0 |
| NFZ | Test, Creatinine, Over The Counter | Class II | 21 CFR 862.1225 | 0 | 0 |
| NGA | Test, Follicle Stimulating Hormone (Fsh), Over The Counter | Class I | 21 CFR 862.1300 | 2 | 2 |
| NGB | Test, Glycosylated Hemoglobin, Over The Counter | Class II | 21 CFR 864.7470 | 0 | 0 |
| NGD | Test, Lactic Acid, Over The Counter | Class I | 21 CFR 862.1450 | 0 | 0 |
| NGE | Test, Luteinizing Hormone (Lh), Over The Counter | Class I | 21 CFR 862.1485 | 6 | 10 |
| NGG | Test, Methamphetamine, Over The Counter | Class II | 21 CFR 862.3610 | 1 | 1 |
| NGI | Test, Morphine, Over The Counter | Class II | 21 CFR 862.3640 | 0 | 0 |
| NGJ | Test, Nitrite, Urinary, Non-Quantitative, Over The Counter | Class I | 21 CFR 862.1510 | 1 | 1 |
| NGK | Test, Occult Blood, Over The Counter | Class II | 21 CFR 864.6550 | 0 | 0 |
| NGL | Test, Opiates, Over The Counter | Class II | 21 CFR 862.3650 | 23 | 0 |
| NGM | Test, Phencyclidine (Pcp), Over The Counter | Unclassified | 0 | 0 | |
| NGO | Test, Triglycerides, Over The Counter | Class I | 21 CFR 862.1705 | 0 | 0 |
| NGR | Tester, Stiffness, Cartilage, Arthroscopic | Class II | 21 CFR 888.1100 | 2 | 0 |
| NGS | Assay, Endotoxin Activity, Chemiluminescent | Class II | 21 CFR 866.3210 | 2 | 0 |
| NGT | Saline, Vascular Access Flush | Class II | 21 CFR 880.5200 | 40 | 61 |
| NGU | Balloon, Liver Tamponade | Class II | 21 CFR 876.5980 | 1 | 0 |
| NGV | System, Appendage Closure, Left Atrial | Class III | 0 | 3 | |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | Class II | 21 CFR 890.5850 | 163 | 3 |
| NGY | Cannula, Trocar, Ophthalmic | Class I | 21 CFR 886.4350 | 1 | 11 |
| NGZ | Susceptibility Test Plate, Antifungal | Class II | 21 CFR 866.1640 | 21 | 4 |
| NHA | Abutment, Implant, Dental, Endosseous | Class II | 21 CFR 872.3630 | 715 | 225 |
| NHB | Polymer, Ear, Nose And Throat, Synthetic, Absorbable | Class II | 21 CFR 874.3620 | 16 | 15 |
| NHC | Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents) | Class II | 21 CFR 882.4100 | 3 | 2 |
| NHF | Monitor, Orthotic/Prosthetic | Class I | 21 CFR 890.3025 | 0 | 0 |
| NHG | Enzyme Immunoassay, Cortisol, Salivary | Class II | 21 CFR 862.1205 | 7 | 5 |
| NHH | Device, Discharge, Electrostatic (For Pain Relief) | Class II | 21 CFR 890.5500 | 2 | 0 |
| NHI | Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief | Class II | 21 CFR 882.5890 | 13 | 0 |
| NHJ | Device, Positive Pressure Breathing, Intermittent | Class II | 21 CFR 868.5905 | 26 | 17 |
| NHK | Resuscitator, Manual, Non Self-Inflating | Class II | 21 CFR 868.5905 | 10 | 0 |
| NHL | Stimulator, Electrical, Implanted, For Parkinsonian Symptoms | Class III | 0 | 4 | |
| NHM | Sheet, Recording, Breast Examination | Class II | 21 CFR 884.2990 | 2 | 0 |
| NHN | Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy | Class II | 21 CFR 890.5500 | 54 | 7 |
| NHO | Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | Class II | 21 CFR 868.1500 | 0 | 0 |
| NHP | Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | Class II | 21 CFR 868.1500 | 1 | 0 |
| NHQ | Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | Class II | 21 CFR 868.1500 | 0 | 0 |
| NHS | Assay, Genotype, Hiv Drug Resistance, In Vitro | Class II | 21 CFR 866.3950 | 0 | 0 |
