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 2026-10-05, the FDA export date. FDA product classification database

Review panels

6,880 codes

FDA review panels and the number of ingested product codes in each
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

214 codes carry no review panel in the FDA classification file and appear only in the index below

7,094 product codes, page 48 of 71

FDA product codes, page 48 of 71
Code	Device name	Class	Regulation	Clearances	Recalls
NHT	Assay, Nucleic Acid Amplification, Bacillus Anthracis	Class II	21 CFR 866.3045	6	1
NHV	System, Water Purification, General Medical Use	Class II	21 CFR 876.5665	12	0
NHW	Electrode, Pacing And Cardioversion, Temporary, Epicardial	Class II	21 CFR 870.3680	2	0
NHX	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)	Class II	21 CFR 866.5775	21	9
NHY	Assay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus	Class I	21 CFR 866.3480	0	0
NHZ	Assay, Direct, Nucleic Acid Amplification, Parainfluenza Virus	Class I	21 CFR 866.3400	0	0
NIA	Assay, Direct, Nucleic Acid Amplification, Influenza Virus	Class I	21 CFR 866.3330	0	0
NIC	Lens, Contact, For Reading Discomfort	Class II	21 CFR 886.5925	1	0
NID	Assay, Proliferation, In Vitro, T Lymphocyte	Class II	21 CFR 864.5220	2	0
NIE	Catheter, Hemodialysis, Triple Lumen, Non-Implanted	Class II	21 CFR 876.5540	12	38
NIF	Catheter, Hemodialysis, Triple Lumen, Implanted	Class II	21 CFR 876.5540	0	0
NIG	System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer	Class II	21 CFR 866.6010	12	19
NIH	Disinfectant, Subsystem, Water Purification	Class II	21 CFR 876.5665	1	0
NII	Disinfectant, Dialysate Delivery System	Class II	21 CFR 876.5860	2	0
NIJ	System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species	Class II	21 CFR 866.1640	6	0
NIK	Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)	Class III		0	153
NIM	Stent, Carotid	Class III		0	25
NIN	Stent, Renal	Class III		0	1
NIO	Stent, Iliac	Class III		0	7
NIP	Stent, Superficial Femoral Artery	Class III		0	86
NIQ	Coronary Drug-Eluting Stent	Class III		0	6
NIU	Stent, Superficial Femoral Artery, Drug-Eluting	Class III		0	3
NIV	Coronary Covered Stent	Humanitarian device exemption		0	0
NIX	Hearing Aid, Air Conduction, Transcutaneous System	Class II	21 CFR 874.3950	2	0
NIY	Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis	Class II	21 CFR 866.5660	3	0
NIZ	Lens, Iris Reconstruction	Class III	21 CFR 886.3600	0	0
NJA	Accessory, System, External Fixator, Containing Antimicrobial Agent	Class II	21 CFR 888.3040	0	0
NJB	Orthosis, Truncal, For Dysmenorrhea	Class I	21 CFR 890.3490	1	0
NJC	Clip, Vas Deferens	Class II	21 CFR 878.4300	2	0
NJD	Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer	Class II	21 CFR 888.3535	5	0
NJE	Intracranial Neurovascular Stent	Humanitarian device exemption		0	7
NJF	Antibodies, Anti-Actin, Anti-Smooth Muscle	Class II	21 CFR 866.5120	1	0
NJG	Flasher, Afterimage, Ophthalmic	Class II	21 CFR 886.1300	0	0
NJH	Lens, Spectacle (Prescription), For Reading Discomfort	Class I	21 CFR 886.5844	2	0
NJJ	Tonometer, Analyzer, Ocular Blood Flow	Class II	21 CFR 886.1930	1	0
NJK	Valve, Pulmonary	Class III		0	3
NJL	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing	Class III		0	269
NJM	Bracket, Ceramic, Orthodontic	Class II	21 CFR 872.5470	60	1
NJO	System, Mycolic Acid Analysis, Mycobacterium Tuberculosis	Class I	21 CFR 866.3370	1	0
NJR	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test	Class I	21 CFR 866.3740	18	11
NJT	Immunohistochemistry Reagents And Kits	Class I	21 CFR 864.1860	0	92
NJU	Suture, Nonabsorbable, Nitinol	Class II	21 CFR 878.4495	2	0
NJV	Test, Albumin Cobalt Binding	Class II	21 CFR 862.1215	2	0
NJW	Control Material, Her-2/Neu, Immunohistochemistry	Class II	21 CFR 864.1860	2	0
NJZ	Extractor, Vein	Class I	21 CFR 878.4800	0	0
NKA	System, Documentation, Breast Lesion	Class II	21 CFR 884.2990	4	0
NKB	Thoracolumbosacral Pedicle Screw System	Class II	21 CFR 888.3070	910	182
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Class I	21 CFR 884.1730	0	3
NKE	Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	Class III		0	28
NKF	Immunohistochemistry Antibody Assay, C-Kit	Class III	21 CFR 864.1860	0	1
NKG	Posterior Cervical Screw System	Class II	21 CFR 888.3075	119	6
NKI	Goniometer With Electrodes	Class II	21 CFR 888.1500	1	0
NKJ	Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter	Class I	21 CFR 872.3540	0	0
NKK	Needle, Hypodermic, Single Lumen, Reprocessed	Class II	21 CFR 880.5570	0	0
NKM	Mitral Valve Repair Devices	Class III		0	6
NKN	Syringe, Piston, Reprocessed	Class II	21 CFR 880.5860	0	0
NKO	System, Balloon, Intra-Aortic And Control, Reprocessed	Class III	21 CFR 870.3535	0	0
NKP	Injector, Contrast Medium, Automatic, Reprocessed	Class II	21 CFR 870.1650	0	0
NKQ	Guidewire, Catheter, Reprocessed	Class II	21 CFR 870.1330	0	1
NKR	System, Catheter Control, Reprocessed	Class II	21 CFR 870.1290	0	0
NKS	Catheter, Steerable, Reprocessed	Class II	21 CFR 870.1280	0	0
NKT	Injector And Syringe, Angiographic, Reprocessed	Class II	21 CFR 870.1650	0	0
NKU	Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed	Class II	21 CFR 870.1650	1	1
NKW	Actuator, Syringe, For Injector, Reprocessed	Class II	21 CFR 870.1670	0	0
NKX	Needle, Phacoemulsification, Reprocessed	Class II	21 CFR 886.4670	5	11
NKY	Blade, Keratome, Reprocessed	Class I	21 CFR 886.4370	0	0
NKZ	Endoilluminator, Reprocessed	Class II	21 CFR 876.1500	0	0
NLA	Knife, Ophthalmic, Reprocessed	Class I	21 CFR 886.4350	0	0
NLB	Trocar, Tracheal, Laryngeal, Sinus, Reprocessed	Class I	21 CFR 874.4420	0	0
NLC	Bracket, Plastic, Orthodontic, Reprocessed	Class II	21 CFR 872.5470	0	0
NLD	Instrument, Diamond, Dental, Reprocessed	Class I	21 CFR 872.4535	0	0
NLE	Forceps, Biopsy, Bronchoscope (Non-Rigid), Reprocessed	Class II	21 CFR 874.4680	0	0
NLF	Oximeter, Reprocessed	Class II	21 CFR 870.2700	27	3
NLG	Catheter, Intracardiac Mapping, High-Density, Reprocessed	Class II	21 CFR 870.1220	3	0
NLH	Catheter, Recording, Electrode, Reprocessed	Class II	21 CFR 870.1220	70	48
NLI	Catheter, Angiography, Reprocessed	Class II	21 CFR 870.1200	1	1
NLJ	Stripper, Vein, External, Reprocessed	Class II	21 CFR 870.4885	0	0
NLK	Needle, Biopsy, Cardiovascular, Reprocessed	Class I	21 CFR 878.4800	0	0
NLL	Staple, Implantable, Reprocessed	Class II	21 CFR 878.4750	3	0
NLM	Laparoscope, General & Plastic Surgery, Reprocessed	Class II	21 CFR 876.1500	23	18
NLN	Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed	Class II	21 CFR 882.4310	1	0
NLO	Drills, Burrs, Trephines And Accessories (Manual), Reprocessed	Class II	21 CFR 882.4300	0	0
NLP	Drills, Burrs, Trephines, And Accessories (Powered Compound), Reprocessed	Class II	21 CFR 882.4305	0	0
NLQ	Single-Use Reprocessed Ultrasonic Surgical Instruments	Unclassified		27	7
NLR	Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed	Class II	21 CFR 876.4300	1	0
NLS	Instrument, Biopsy, Reprocessed	Class II	21 CFR 876.1075	0	0
NLT	Snare, Flexible, Reprocessed	Class II	21 CFR 876.4300	0	0
NLU	Forceps, Biopsy, Electric, Reprocessed	Class II	21 CFR 876.4300	4	1
NLV	Electrode, Flexible Suction Coagulator, Reprocessed	Class II	21 CFR 876.4300	0	0
NLW	Electrode, Electrosurgical, Active, Urological, Reprocessed	Class II	21 CFR 876.4300	1	1
NLX	Needle, Pneumoperitoneum, Spring Loaded, Reprocessed	Class II	21 CFR 876.1500	0	0
NLY	Microdebrider, Ent, High Speed, Single Use, Reprocessed	Class I	21 CFR 874.4140	1	0
NLZ	Bur, Ent, Diamond Coated, Single Use, Reprocessed	Class I	21 CFR 874.4140	0	0
NMA	Tube, Tracheal, Reprocessed	Class II	21 CFR 868.5730	0	0
NMB	Catheter, Oximeter, Fiber Optic, Reprocessed	Class II	21 CFR 870.1230	0	0
NMC	Mask, Ventilator, Non-Continuous, Reprocessed	Class II	21 CFR 868.5905	0	0
NMD	Oximeter, Tissue Saturation, Reprocessed	Class II	21 CFR 870.2700	2	0
NME	Bur, Diamond Coated, Reprocessed	Class I	21 CFR 872.3240	0	1
NMF	Clamp, Vascular, Reprocessed	Class II	21 CFR 870.4450	3	2
NMG	Forceps, Biopsy, Gynecological, Reprocessed	Class II	21 CFR 884.4530	0	0