Device classification
Every device type FDA has classified: class, product code, regulation and whether it needs a 510(k) or PMA. 7,098 records; openFDA updated it 2026-11-09. About this dataset
Records
- Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted InfectionsFDA page
Microbiology · 21 CFR 866.3393
- Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)FDA page
Immunology · 21 CFR 866.5660
- Scanner, ColorFDA page
Dental · 21 CFR 872.3661
- FDA page
- Prosthesis, Eyelid Spacer/Graft, PolymerFDA page
Ophthalmic · 21 CFR 886.3130
- Immunoassay Blood Test For Amyloid Pathology AssessmentFDA page
Immunology · 21 CFR 866.5840
- Tympanic Membrane Direct Contact Hearing AidFDA page
Ear, Nose, Throat · 21 CFR 874.3315
- Antigen, Indirect Fluorescent Antibody Test, Echinococcus GranulosusFDA page
Microbiology · 21 CFR 866.3200
- Cement, Ear, Nose And ThroatFDA page
Dental · 21 CFR 872.3275
- Prosthesis, Finger, Constrained, Metal/PolymerFDA page
Orthopedic · 21 CFR 888.3220
- Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic DeepFDA page
Orthopedic · 21 CFR 890.5870
- Scissors For Cytoscope, ExemptFDA page
Gastroenterology, Urology · 21 CFR 876.1500
- Flowmeter, Tube, Thorpe, Back-Pressure CompensatedFDA page
Anesthesiology · 21 CFR 868.2340
- Polymer, Composite Synthetic Ptfe With Carbon-Fiber, EntFDA page
General, Plastic Surgery · 21 CFR 878.3500
- Catheter, SeptostomyFDA page
Cardiovascular · 21 CFR 870.5175
- Hysteroscope (And Accessories)FDA page
Obstetrics/Gynecology · 21 CFR 884.1690
- Method, Ion-Exchange, AmmoniaFDA page
Clinical Chemistry · 21 CFR 862.1065
- Alpha 2, 2n-Glycoprotein, Antigen, Antiserum, ControlFDA page
Immunology · 21 CFR 866.5425
- FDA page
- Monitor, Bed PatientFDA page
General Hospital · 21 CFR 880.2400
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.
