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 |
|---|---|---|---|---|---|
| LTO | Spacer, Cement | Class III | 21 CFR 888.3320 | 0 | 0 |
| LTQ | Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum | Class III | 0 | 0 | |
| LTS | Test Reagents, Neisseria Gonorrhoeae Biochemical | Class I | 21 CFR 866.2660 | 1 | 0 |
| LTT | Panels, Test, Susceptibility, Antimicrobial | Class II | 21 CFR 866.1640 | 50 | 13 |
| LTW | Susceptibility Test Cards, Antimicrobial | Class II | 21 CFR 866.1640 | 16 | 39 |
| LTX | Discs, Elution | Class II | 21 CFR 866.1620 | 2 | 0 |
| LTY | Fluid, Cytological Collection | Class III | 0 | 0 | |
| LTZ | Condom With Nonoxynol-9 | Class II | 21 CFR 884.5310 | 22 | 1 |
| LWA | Prosthesis, Ligament, Ptfe | Class III | 0 | 0 | |
| LWB | Stimulator, Functional Neuromuscular, Scoliosis | Class III | 0 | 0 | |
| LWE | Bone Marrow Collection/Transfusion Kit | Class II | 3 | 1 | |
| LWF | Dilator, Nasal | Class I | 21 CFR 874.3900 | 20 | 0 |
| LWG | Surgical Table Cushion | Class I | 21 CFR 878.4950 | 4 | 1 |
| LWH | Counter, Sponge, Surgical | Class I | 21 CFR 880.2740 | 15 | 4 |
| LWI | Ultrasound, Sinus | Class II | 21 CFR 892.1560 | 4 | 0 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Class II | 21 CFR 888.3360 | 81 | 26 |
| LWK | Razor, Surgical | Class I | 21 CFR 878.4800 | 4 | 6 |
| LWL | Fluid, Intraocular | Class III | 21 CFR 886.4275 | 1 | 0 |
| LWM | Device, Electrical Dental Anesthesia | Unclassified | 15 | 0 | |
| LWO | Pulse-Generator, Single Chamber, Sensor Driven, Implantable | Class III | 0 | 0 | |
| LWP | Implantable Pulse Generator, Pacemaker (Non-Crt) | Class III | 0 | 113 | |
| LWQ | Heart-Valve, Mechanical | Class III | 0 | 5 | |
| LWR | Heart-Valve, Non-Allograft Tissue | Class III | 0 | 7 | |
| LWS | Implantable Cardioverter Defibrillator (Non-Crt) | Class III | 0 | 219 | |
| LWT | Occluder, Balloon, Vena-Cava | Class III | 0 | 0 | |
| LWW | Pulse-Generator, Single Chamber, Single | Class III | 0 | 0 | |
| LWX | Device. Laser Peripheral Angioplasty | Class III | 0 | 0 | |
| LWZ | Tissue Graft Of Less Than 6mm | Class III | 2 | 0 | |
| LXA | Tissue Graft Of 6mm And Greater | Class III | 0 | 4 | |
| LXB | Hearing Aid, Bone Conduction | Class II | 21 CFR 874.3302 | 53 | 7 |
| LXC | Monitor, Pressure, Intracompartmental | Unclassified | 15 | 2 | |
| LXE | Doppler, Fetal, Ultrasound | Class II | 21 CFR 884.2660 | 0 | 0 |
| LXF | Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat | Class III | 21 CFR 890.5300 | 0 | 0 |
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Class I | 21 CFR 862.2050 | 3 | 28 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | 21 CFR 888.4540 | 58 | 526 |
| LXI | Guide, Drill, Ligament | Class I | 21 CFR 878.4820 | 8 | 0 |
| LXJ | Interactive Rehabilitation Exercise Devices | Class II | 21 CFR 890.5360 | 27 | 0 |
| LXK | Scrapper, Skin Specimen | Class I | 21 CFR 878.4800 | 1 | 0 |
| LXM | Manipulator, Plunger-Like Joint | Unclassified | 32 | 1 | |
| LXN | Probe, Test, Heart-Valve | Class I | 21 CFR 870.4500 | 2 | 0 |
| LXP | Plug, Scleral | Class II | 21 CFR 886.4155 | 10 | 0 |
| LXQ | Cup, Eye | Unclassified | 5 | 0 | |
| LXR | Laser, Microsurgical Argon, For Use In Otology | Class II | 21 CFR 874.4490 | 0 | 0 |
| LXS | Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla | Class II | 21 CFR 886.4392 | 6 | 1 |
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | Class II | 21 CFR 888.3030 | 57 | 14 |
| LXU | Laser For Wound Healing | Class III | 0 | 0 | |
| LXV | Apparatus, Vestibular Analysis | Unclassified | 22 | 2 | |
| LXW | Column, Adsorption, Low Density, Lipoprotein | Class III | 1 | 0 | |
| LXY | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Polymer/Metal/Polymer | Class III | 0 | 0 | |
| LXZ | Guard, Instrument | Class I | 21 CFR 878.4800 | 2 | 0 |
| LYA | Splint, Intranasal Septal | Class I | 21 CFR 874.4780 | 46 | 2 |
| LYC | Bone Grafting Material, Synthetic | Class II | 21 CFR 872.3930 | 231 | 14 |
| LYE | Cytokeratins | Class II | 21 CFR 866.5550 | 2 | 0 |
| LYF | Pneumocystis Carinii | Class II | 21 CFR 866.3780 | 7 | 0 |
| LYG | Massager, Therapeutic, Manual | Class I | 21 CFR 890.5660 | 13 | 0 |
| LYH | Arthrometer | Class I | 21 CFR 890.1615 | 5 | 0 |
| LYI | Stimulator, Subcortical, Implanted For Epilepsy | Class III | 0 | 0 | |
| LYJ | Stimulator, Autonomic Nerve, Implanted For Epilepsy | Class III | 0 | 37 | |
| LYK | Angioscope | Class II | 21 CFR 876.1500 | 41 | 0 |
| LYL | Accessories, Solution, Ultrasonic Cleaners For Lenses | Class II | 21 CFR 886.5928 | 22 | 14 |
| LYN | Apparatus, Visual Reinforcement Audiometric | Class II | 21 CFR 874.1050 | 3 | 0 |
| LYP | Accessories, Fixation, Spinal Interlaminal | Class II | 21 CFR 888.3050 | 1 | 0 |
| LYQ | Accessories, Fixation, Spinal Intervertebral Body | Class I | 21 CFR 888.4540 | 3 | 2 |
| LYR | Helicobacter Pylori | Class I | 21 CFR 866.3110 | 91 | 11 |
| LYS | Bone Mill | Class I | 21 CFR 888.4540 | 4 | 1 |
| LYT | Fixation Accessory | Class II | 21 CFR 888.3030 | 9 | 4 |
| LYU | Accessory, Surgical Apparel | Class I | 21 CFR 878.4040 | 56 | 9 |
| LYV | Label Or Tag, Sterile | Class I | 21 CFR 878.4800 | 2 | 0 |
| LYX | Media, Corneal Storage | Unclassified | 21 | 0 | |
| LYY | Latex Patient Examination Glove | Class I | 21 CFR 880.6250 | 1,954 | 6 |
| LYZ | Vinyl Patient Examination Glove | Class I | 21 CFR 880.6250 | 799 | 7 |
| LZA | Polymer Patient Examination Glove | Class I | 21 CFR 880.6250 | 1,180 | 10 |
| LZB | Finger Cot | Class I | 21 CFR 880.6250 | 5 | 1 |
| LZC | Medical Glove, Specialty | Class I | 21 CFR 880.6250 | 79 | 8 |
| LZD | Joint, Temporomandibular, Implant | Class III | 21 CFR 872.3940 | 0 | 20 |
| LZE | Isometer | Class I | 21 CFR 888.1520 | 1 | 0 |
| LZF | Pump, Infusion, Analytical Sampling | Class II | 21 CFR 880.5725 | 7 | 1 |
| LZG | Pump, Infusion, Insulin | Class II | 21 CFR 880.5725 | 85 | 126 |
| LZH | Pump, Infusion, Enteral | Class II | 21 CFR 880.5725 | 34 | 24 |
| LZI | Device, Assistive Listening | Class II | 21 CFR 874.3320 | 7 | 0 |
| LZJ | Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained | Unclassified | 11 | 1 | |
| LZK | Implant, Malar | Class II | 21 CFR 878.3550 | 40 | 4 |
| LZL | Micro-Condom | Class III | 21 CFR 884.5320 | 0 | 0 |
| LZM | Guard, Skin Graft | Class I | 21 CFR 878.4014 | 2 | 0 |
| LZN | Cement Obturator | Class II | 21 CFR 878.3300 | 37 | 8 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | 21 CFR 888.3353 | 534 | 177 |
| LZP | Aid, Surgical, Viscoelastic | Class III | 21 CFR 886.4275 | 0 | 25 |
| LZQ | Tissue Adhesive For Ophthalmic Use | Class III | 0 | 0 | |
| LZR | Ultrasound, Cyclodestructive | Class II | 21 CFR 886.5350 | 0 | 0 |
| LZS | Excimer Laser System | Class III | 0 | 29 | |
| LZU | Plug, Punctum | Unclassified | 49 | 4 | |
| LZV | System, Cement Removal Extraction | Class II | 21 CFR 888.4580 | 7 | 0 |
| LZW | Monitor, Spine Curvature | Unclassified | 5 | 0 | |
| LZY | Prosthesis, Hip, Hemi-, Femoral, Metal Ball | Class II | 21 CFR 888.3360 | 8 | 3 |
| MAA | Monitor, Fetal Doppler Ultrasound | Class II | 21 CFR 884.2660 | 9 | 3 |
| MAB | Marker, Cardiopulmonary Bypass (Vein Marker) | Class II | 21 CFR 870.3450 | 3 | 0 |
| MAC | Decontamination Kit | Class I | 21 CFR 878.4014 | 2 | 1 |
| MAD | Catheter, Percutaneous (Valvuloplasty) | Class III | 0 | 0 | |
| MAE | Occluder, Patent Ductus, Arteriosus | Class III | 0 | 5 | |
| MAF | Stent, Coronary | Class III | 0 | 22 |
