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 56 of 71

FDA product codes, page 56 of 71
Code	Device name	Class	Regulation	Clearances	Recalls
OVX	Water Immersion Labor Pool	Not classified		0	0
OVY	Liquid Chemical Processing System	Class II	21 CFR 880.6887	4	0
OVZ	Pin, Fixation, Resorbable, Hard Tissue	Class II	21 CFR 888.3040	3	0
OWB	Interventional Fluoroscopic X-Ray System	Class II	21 CFR 892.1650	325	624
OWD	Somatic Gene Mutation Detection System	Class III		0	13
OWE	Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement	Class II	21 CFR 864.1890	0	0
OWF	Immunohistochemical Assay, Helicobacter Pylori	Class I	21 CFR 866.3110	1	2
OWI	Bone Fixation Cerclage, Sublaminar	Class II	21 CFR 888.3010	37	2
OWK	Early Growth Response 1 (Egr) Fish Probe Kit	Class II	21 CFR 866.6040	1	0
OWL	Peripheral Catheter Insertion Kit	Class II	21 CFR 880.5200	0	17
OWM	Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers	Class II	21 CFR 866.6040	1	0
OWN	Confocal Optical Imaging	Class II	21 CFR 876.1500	63	4
OWO	Drug-Eluting Sinus Stent	Class III		0	1
OWP	Biological Sterilization Process Indicator With Recombinant-Dna Plasmid	Class II	21 CFR 880.2805	5	0
OWQ	Reprocessed Intravascular Ultrasound Catheter	Class II	21 CFR 870.1200	31	10
OWR	Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery	Class II	21 CFR 878.3300	1	0
OWS	Mesh, Surgical, Collagen, Plastics, Facial Implants	Class II	21 CFR 878.3300	0	0
OWT	Mesh, Surgical, Absorbable, Abdominal Hernia	Class II	21 CFR 878.3300	11	0
OWU	Mesh, Surgical, Non-Absorbable, Diaphragmatic Hernia	Class II	21 CFR 878.3300	0	0
OWV	Mesh, Surgical, Collagen, Diaphragmatic Hernia	Class II	21 CFR 878.3300	1	1
OWW	Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon	Class II	21 CFR 878.3300	10	3
OWX	Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon	Class II	21 CFR 878.3300	5	0
OWY	Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon	Class II	21 CFR 878.3300	14	0
OWZ	Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction	Class II	21 CFR 878.3300	0	0
OXA	Mesh, Surgical, Non-Absorbable, Thoracic, Chest Wall Reconstruction	Class II	21 CFR 878.3300	0	0
OXB	Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction	Class II	21 CFR 878.3300	0	0
OXC	Mesh, Surgical, Absorbable, Staple Line Reinforcement	Class II	21 CFR 878.3300	9	0
OXD	Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement	Class II	21 CFR 878.3300	3	0
OXE	Mesh, Surgical, Collagen, Staple Line Reinforcement	Class II	21 CFR 878.3300	4	0
OXF	Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery	Class II	21 CFR 878.3300	8	0
OXG	Mesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery	Class II	21 CFR 878.3300	0	0
OXH	Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	Class II	21 CFR 878.3300	5	0
OXI	Mesh, Surgical, Absorbable, Large Abdominal Wall Defects	Class II	21 CFR 878.3300	0	0
OXJ	Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects	Class II	21 CFR 878.3300	2	0
OXK	Mesh, Surgical, Collagen, Large Abdominal Wall Defects	Class II	21 CFR 878.3300	2	0
OXL	Mesh, Surgical, Absorbable, Organ Support	Class II	21 CFR 878.3300	0	0
OXM	Mesh, Surgical, Absorbable, Fistula	Class II	21 CFR 878.3300	0	0
OXN	Mesh, Surgical, Collagen, Fistula	Class II	21 CFR 878.3300	1	0
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Class II	21 CFR 892.1650	82	49
OXP	Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment	Class II	21 CFR 866.6010	1	0
OXQ	Dressing Change Tray	Class I	21 CFR 880.5075	0	69
OXR	5-Fluorouracil Assay	Not classified		0	0
OXT	Percutaneous Surgical Set With Attachments	Class II	21 CFR 878.4805	1	0
OXW	Stimulator, Electrical, Transcutaneous, For Diabetic Retinopathy	Not classified		0	0
OXZ	Pediatric/Child Facemask	Class II	21 CFR 878.4040	9	0
OYA	P2psa	Class III		0	1
OYB	Kit, Rna Detection, Human Papillomavirus	Class III		0	1
OYC	Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor	Class III		0	34
OYD	Optical Diagnostic Device For Melanoma Detection	Class II	21 CFR 878.1820	0	1
OYE	Flow Cytometric Reagents And Accessories.	Class II	21 CFR 864.5220	8	26
OYF	Aspiration Therapy System	Class III		0	0
OYG	St2 Assay	Class II	21 CFR 862.1117	1	1
OYH	Orthodontic Vibratory Accessory	Class II	21 CFR 872.5470	5	0
OYI	Non-Bronchoscopic Bronchoalveolar Lavage Catheter	Class I	21 CFR 868.6810	1	0
OYJ	Dna Specimen Collection, Saliva	Class II	21 CFR 862.1675	7	1
OYK	Ankle Arthroplasty Implantation System	Class II	21 CFR 888.3110	7	2
OYL	Tryptase Assay System	Class II	21 CFR 866.5760	2	0
OYM	Prostrate Cancer Genes Nucleic Acid Amplification Test System	Class III		0	0
OYO	Culture, Intravaginal, Assisted Reproduction	Class II	21 CFR 884.6165	2	0
OYP	Anti-Jcv Antibody Detection Assay	Class II	21 CFR 866.3336	2	1
OYR	Filler, Bone Void, Recombinant Platelet-Derived Growth Factor	Not classified		0	0
OYS	Patient Bed With Canopy/Restraints	Class I	21 CFR 880.6760	3	1
OYU	Dna-Probe Kit, Human Chromosome	Class II	21 CFR 866.4700	3	1
OYV	Inherited Nucleotide Repeat Disorder Dna Test	Class II	21 CFR 866.5970	1	0
OYW	Laser, Cellulite Appearance	Class II	21 CFR 878.4810	2	0
OYX	Bcr/Abl1 Monitoring Test	Class II	21 CFR 866.6060	6	3
OYY	Leukemia Translocation Panel Multiplex Test	Not classified		0	0
OYZ	Group A Streptococcus Nucleic Acid Amplification Assay System	Class I	21 CFR 866.3740	1	0
OZA	Test, Urea Adult And Pediatric (Breath),	Class III	21 CFR 866.3110	0	0
OZB	Dengue Nucleic Acid Amplification Assay (Naat)	Class II	21 CFR 866.3946	1	0
OZC	Over The Counter Thermal Treatment For Acne.	Class II	21 CFR 890.5740	1	0
OZD	Temporary Non-Roller Type Left Heart Support Blood Pump	Class III		0	47
OZE	Influenza A And Influenza B Multiplex Nucleic Acid Assay	Class II	21 CFR 866.3980	20	5
OZF	Tissue Rna Preservative For Collection, Storage, And Transportation	Class II	21 CFR 866.4070	1	0
OZG	Transcatheter Septal Occluder (Atrial)	Class III		0	0
OZH	Transcatheter Septal Occluder (Ventricular)	Class III		0	0
OZI	Internal Hinged Elbow Fixator	Class II	21 CFR 888.3030	3	0
OZJ	Inhibitor, Postoperative Fibrosis (Adhesion Barrier)	Not classified		0	0
OZK	Thermometer, Exhaled Breath	Class II	21 CFR 880.2910	0	0
OZN	C. Difficile Toxin Gene Amplification Assay	Class II	21 CFR 866.3130	18	8
OZO	Automated Insulin Dosing , Threshold Suspend	Class III		0	11
OZP	Automated Insulin Dosing Device System, Single Hormonal Control	Class III		0	23
OZQ	Automated Insulin Dosing Device System, Bihormonal Control	Class III		0	0
OZR	Intraoral Pressure Gradient Device	Class II	21 CFR 872.5570	6	0
OZT	Balloon Aortic Valvuloplasty	Class II	21 CFR 870.1255	22	2
OZW	Ingestible Event Marker	Class II	21 CFR 880.6305	8	0
OZX	Mycoplasma Pneumoniae Dna Assay System	Class II	21 CFR 866.3980	3	0
OZY	Chlamydophila Pneumoniae Dna Assay System	Class II	21 CFR 866.3980	0	0
OZZ	Bordetella Pertussis Dna Assay System	Class II	21 CFR 866.3980	9	2
PAA	Automated Breast Ultrasound	Class III		0	1
PAB	Cytomegalovirus (Cmv) Dna Quantitative Assay	Class II	21 CFR 866.3180	3	1
PAD	Chest Drainage Kit	Class II	21 CFR 880.6740	0	20
PAE	Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography	Class II	21 CFR 890.3450	1	0
PAF	Voltage Gated Calcium Channel (Vgcc) Antibody Assay	Class II	21 CFR 866.5660	1	0
PAG	Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	Class II	21 CFR 878.3300	9	0
PAH	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling	Class II	21 CFR 878.3300	20	1
PAI	Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed	Class III	21 CFR 884.5980	2	0
PAJ	Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	Class II	21 CFR 878.3300	2	0
PAL	Pulmonic Replacement Heart Valve	Humanitarian device exemption	21 CFR 870.3925	0	0
PAM	Gram-Positive Bacteria And Their Resistance Markers	Class II	21 CFR 866.3365	7	11