FDA product codes
FDA device product codes, with their 510(k) history
Every product code with at least 10 dated 510(k) decisions since 2018: 463 codes covering 23,405 clearances. Each page gives the code's class and regulation, its review-time percentiles with n, its public record counts and the FDA-recognized standards that cite it.
Don't know the code? Search by device name in PredicateScope or look up any code in the Device Data Snapshot. Codes with fewer clearances are in the Clearance Timeline Estimator.
Anesthesiology
- BSK Cuff, Tracheal Tube, Inflatable median 185 d · n 11
- BSP Needle, Conduction, Anesthetic (W/Wo Introducer) median 226 d · n 25
- BTR Tube, Tracheal (W/Wo Connector) median 248 d · n 26
- BTT Humidifier, Respiratory Gas, (Direct Patient Interface) median 245 d · n 32
- BTY Calculator, Predicted Values, Pulmonary Function median 267 d · n 10
- BWF Spirometer, Therapeutic (Incentive) median 265 d · n 11
- BZD Ventilator, Non-Continuous (Respirator) median 212 d · n 58
- BZG Spirometer, Diagnostic median 231 d · n 20
- BZH Meter, Peak Flow, Spirometry median 232 d · n 13
- BZQ Monitor, Breathing Frequency median 225 d · n 22
- CAF Nebulizer (Direct Patient Interface) median 235 d · n 51
- CAW Generator, Oxygen, Portable median 224 d · n 44
- CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) median 203 d · n 10
- CBK Ventilator, Continuous, Facility Use median 266 d · n 44
- CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase median 258 d · n 37
- DQA Oximeter median 210 d · n 131
- KOI Stimulator, Nerve, Peripheral, Electric median 191 d · n 13
- MNR Ventilatory Effort Recorder median 189 d · n 53
- MRN Apparatus, Nitric Oxide Delivery median 127 d · n 13
Cardiovascular
- CAC Apparatus, Autotransfusion median 117 d · n 14
- DPS Electrocardiograph median 232 d · n 61
- DPW Flowmeter, Blood, Cardiovascular median 132 d · n 19
- DQD Stethoscope, Electronic median 150 d · n 48
- DQK Computer, Diagnostic, Programmable median 121 d · n 157
- DQO Catheter, Intravascular, Diagnostic median 127 d · n 37
- DQX Wire, Guide, Catheter median 150 d · n 109
- DQY Catheter, Percutaneous median 104 d · n 177
- DRA Catheter, Steerable median 69 d · n 12
- DRE Dilator, Vessel, For Percutaneous Catheterization median 31 d · n 19
- DRF Catheter, Electrode Recording, Or Probe, Electrode Recording median 146 d · n 29
- DRG Transmitters And Receivers, Physiological Signal, Radiofrequency median 168 d · n 37
- DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) median 242 d · n 14
- DSA Cable, Transducer And Electrode, Patient, (Including Connector) median 130 d · n 30
- DSB Plethysmograph, Impedance median 242 d · n 12
- DSH Recorder, Magnetic Tape, Medical median 228 d · n 32
- DSI Detector And Alarm, Arrhythmia median 198 d · n 12
- DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter median 131 d · n 17
- DTR Heat-Exchanger, Cardiopulmonary Bypass median 128 d · n 10
- DTZ Oxygenator, Cardiopulmonary Bypass median 137 d · n 33
- DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass median 70 d · n 33
- DWJ System, Thermal Regulating median 97 d · n 30
- DXC Clamp, Vascular median 100 d · n 25
- DXF Catheter, Septostomy median 30 d · n 13
- DXH Transmitters And Receivers, Electrocardiograph, Telephone median 193 d · n 28
- DXN System, Measurement, Blood-Pressure, Non-Invasive median 161 d · n 235
- DXO Transducer, Pressure, Catheter Tip median 142 d · n 11
- DXQ Blood Pressure Cuff median 102 d · n 33
- DYB Introducer, Catheter median 61 d · n 136
- JOW Sleeve, Limb, Compressible median 136 d · n 86
- KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type median 143 d · n 14
- KRA Catheter, Continuous Flush median 136 d · n 39
- KRD Device, Vascular, For Promoting Embolization median 104 d · n 48
- KRH Ring, Annuloplasty median 60 d · n 15
- LIT Catheter, Angioplasty, Peripheral, Transluminal median 110 d · n 50
- LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous median 131 d · n 34
- MCW Catheter, Peripheral, Atherectomy median 93 d · n 36
- MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) median 195 d · n 83
- MJN Catheter, Intravascular Occluding, Temporary median 117 d · n 19
- MMX Device, Percutaneous Retrieval median 139 d · n 12
- MSX System, Network And Communication, Physiological Monitors median 188 d · n 36
- MTD Catheter, Intracardiac Mapping, High-Density Array median 168 d · n 15
- MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) median 222 d · n 74
- MWJ Electrocardiograph, Ambulatory (Without Analysis) median 268 d · n 13
- MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) median 57 d · n 23
- NLH Catheter, Recording, Electrode, Reprocessed median 141 d · n 22
- OBJ Catheter, Ultrasound, Intravascular median 66 d · n 30
- OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue median 89 d · n 15
- OWQ Reprocessed Intravascular Ultrasound Catheter median 145 d · n 20
- PDU Catheter For Crossing Total Occlusions median 134 d · n 18
- PNO Catheter, Percutaneous, Cutting/Scoring median 136 d · n 16
- PPN Percutaneous Catheter, Ultrasound median 57 d · n 12
- PZX Left Atrial Appendage Clip, Implantable median 58 d · n 10
- QEW Peripheral Mechanical Thrombectomy With Aspiration median 71 d · n 121
- QEY Mechanical Thrombolysis Catheter median 91 d · n 18
- QEZ Aspiration Thrombectomy Catheter median 94 d · n 25
- QME Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate median 190 d · n 12
Clinical Chemistry
- CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone median 138 d · n 11
- CGA Glucose Oxidase, Glucose median 231 d · n 15
- CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph median 246 d · n 15
- DHA System, Test, Human Chorionic Gonadotropin median 162 d · n 10
- JGS Electrode, Ion Specific, Sodium median 267 d · n 13
- JKA Tubes, Vials, Systems, Serum Separators, Blood Collection median 189 d · n 61
- LCX Kit, Test, Pregnancy, Hcg, Over The Counter median 155 d · n 38
- LZG Pump, Infusion, Insulin median 125 d · n 10
- MMI Immunoassay Method, Troponin Subunit median 266 d · n 19
- NBC Test, Natriuretic Peptide median 262 d · n 11
- NBW System, Test, Blood Glucose, Over The Counter median 193 d · n 71
- NDC Calculator, Drug Dose median 126 d · n 23
- PDJ Hemoglobin A1c Test System median 230 d · n 13
- QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated median 87 d · n 17
- QFG Alternate Controller Enabled Insulin Infusion Pump median 98 d · n 28
- QJI Interoperable Automated Glycemic Controller median 87 d · n 23
Clinical Toxicology
- DJG Enzyme Immunoassay, Opiates median 134 d · n 39
- DKZ Enzyme Immunoassay, Amphetamine median 145 d · n 10
- NFT Test, Amphetamine, Over The Counter median 40 d · n 31
- NGL Test, Opiates, Over The Counter median 36 d · n 21
Dental
- DYH Adhesive, Bracket And Tooth Conditioner, Resin median 108 d · n 13
- DZE Implant, Endosseous, Root-Form median 216 d · n 301
- DZI Drill, Bone, Powered median 201 d · n 12
- DZJ Driver, Wire, And Bone Drill, Manual median 161 d · n 19
- DZL Screw, Fixation, Intraosseous median 258 d · n 13
- EBF Material, Tooth Shade, Resin median 103 d · n 136
- EBG Crown And Bridge, Temporary, Resin median 148 d · n 43
- EBI Resin, Denture, Relining, Repairing, Rebasing median 106 d · n 68
- EBW Controller, Foot, Handpiece And Cord median 269 d · n 21
- EBZ Activator, Ultraviolet, For Polymerization median 144 d · n 27
- EFB Handpiece, Air-Powered, Dental median 252 d · n 31
- EGS Handpiece, Contra- And Right-Angle Attachment, Dental median 198 d · n 14
- EIA Unit, Operative Dental median 270 d · n 22
- EIH Powder, Porcelain median 108 d · n 140
- EKX Handpiece, Direct Drive, Ac-Powered median 266 d · n 29
- ELC Scaler, Ultrasonic median 198 d · n 24
- ELW Material, Impression median 100 d · n 31
- EMA Cement, Dental median 129 d · n 51
- JEY Plate, Bone median 215 d · n 40
- KIF Resin, Root Canal Filling median 104 d · n 58
- KLE Agent, Tooth Bonding, Resin median 115 d · n 54
- LBH Varnish, Cavity median 229 d · n 23
- LFD Saliva, Artificial median 142 d · n 16
- LQY Locator, Root Apex median 218 d · n 11
- LRK Device, Anti-Snoring median 149 d · n 82
- LYC Bone Grafting Material, Synthetic median 267 d · n 11
- MQC Mouthguard, Prescription median 192 d · n 40
- MVL Cord, Retraction median 165 d · n 10
- NHA Abutment, Implant, Dental, Endosseous median 163 d · n 315
- NJM Bracket, Ceramic, Orthodontic median 106 d · n 20
- NPL Barrier, Animal Source, Intraoral median 242 d · n 19
- NPM Bone Grafting Material, Animal Source median 211 d · n 17
- NVK Laser, Dental, Soft Tissue median 191 d · n 16
- NXC Aligner, Sequential median 127 d · n 125
- OAT Implant, Endosseous, Orthodontic median 289 d · n 17
- OBR Mouthguard, Over-The-Counter median 142 d · n 22
- OLR Oral Wound Dressing median 177 d · n 17
- PEM Dental Barriers And Sleeves median 106 d · n 13
- PLV Dental Stereotaxic Instrument median 116 d · n 20
- PNN Orthodontic Software median 160 d · n 32
Ear, Nose, Throat
- EOB Nasopharyngoscope (Flexible Or Rigid) median 187 d · n 38
- EOQ Bronchoscope (Flexible Or Rigid) median 146 d · n 108
- EOX Esophagoscope (Flexible Or Rigid) median 121 d · n 11
- ETN Stimulator, Nerve median 182 d · n 14
- KLW Masker, Tinnitus median 161 d · n 10
- KTI Bronchoscope Accessory median 137 d · n 19
- LXB Hearing Aid, Bone Conduction median 125 d · n 12
- PFO Active Implantable Bone Conduction Hearing System median 114 d · n 11
- PGW Ear, Nose, And Throat Stereotaxic Instrument median 100 d · n 20
- QUH Self-Fitting Air-Conduction Hearing Aid, Over The Counter median 175 d · n 10
Gastroenterology, Urology
- ESW Prosthesis, Esophageal median 127 d · n 17
- EZD Catheter, Straight median 176 d · n 42
- EZL Catheter, Retention Type, Balloon median 169 d · n 32
- FAD Stent, Ureteral median 247 d · n 28
- FAJ Cystoscope And Accessories, Flexible/Rigid median 133 d · n 42
- FBK Endoscopic Injection Needle, Gastroenterology-Urology median 181 d · n 24
- FBN Choledochoscope And Accessories, Flexible/Rigid median 175 d · n 15
- FCG Biopsy Needle median 111 d · n 17
- FDF Colonoscope And Accessories, Flexible/Rigid median 158 d · n 40
- FDI Snare, Flexible median 209 d · n 16
- FDS Gastroscope And Accessories, Flexible/Rigid median 167 d · n 43
- FDT Duodenoscope And Accessories, Flexible/Rigid median 88 d · n 21
- FED Endoscopic Access Overtube, Gastroenterology-Urology median 111 d · n 43
- FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology median 109 d · n 26
- FFX System, Gastrointestinal Motility (Electrical) median 125 d · n 11
- FGB Ureteroscope And Accessories, Flexible/Rigid median 165 d · n 65
- FGE Stents, Drains And Dilators For The Biliary Ducts median 188 d · n 47
- FIP Subsystem, Water Purification median 124 d · n 14
- GBM Catheter, Urethral median 190 d · n 22
- HIR Perineometer median 136 d · n 14
- KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System median 216 d · n 52
- KDN System, Perfusion, Kidney median 168 d · n 22
- KGE Forceps, Biopsy, Electric median 202 d · n 11
- KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) median 137 d · n 48
- KNT Tubes, Gastrointestinal (And Accessories) median 113 d · n 55
- KOD Catheter, Urological median 251 d · n 11
- KPI Stimulator, Electrical, Non-Implantable, For Incontinence median 198 d · n 30
- KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) median 264 d · n 20
- LJE Catheter, Nephrostomy median 245 d · n 12
- LQR Dislodger, Stone, Biliary median 193 d · n 11
- MSD Catheter, Hemodialysis, Implanted median 138 d · n 12
- NEZ System, Imaging, Gastrointestinal, Wireless, Capsule median 130 d · n 14
- OCW Endoscopic Tissue Approximation Device median 133 d · n 12
- OCX Endoscopic Irrigation/Suction System median 107 d · n 41
- ODC Endoscope Channel Accessory median 125 d · n 46
- ODG Endoscopic Ultrasound System, Gastroenterology-Urology median 112 d · n 17
- PIF Gastrointestinal Tubes With Enteral Specific Connectors median 199 d · n 32
- PKL Hemostatic Metal Clip For The Gi Tract median 188 d · n 47
- PNR Enteral Syringes With Enteral Specific Connectors median 157 d · n 20
- QNP Gastrointesinal Lesion Software Detection System median 32 d · n 22
General Hospital
- CAH Filter, Bacterial, Breathing-Circuit median 257 d · n 16
- DXT Injector And Syringe, Angiographic median 154 d · n 29
- FLE Sterilizer, Steam median 136 d · n 46
- FLL Continuous Measurement Thermometer median 211 d · n 183
- FMF Syringe, Piston median 169 d · n 136
- FMI Needle, Hypodermic, Single Lumen median 163 d · n 127
- FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days median 147 d · n 64
- FPA Set, Administration, Intravascular median 232 d · n 84
- FQH Lavage, Jet median 130 d · n 13
- FRA Purifier, Air, Ultraviolet, Medical median 177 d · n 18
- FRC Indicator, Biological Sterilization Process median 102 d · n 64
- FRG Wrap, Sterilization median 222 d · n 65
- FRN Pump, Infusion median 220 d · n 36
- FXX Mask, Surgical median 140 d · n 391
- FYA Gown, Surgical median 170 d · n 85
- FYC Gown, Isolation, Surgical median 186 d · n 24
- JOJ Indicator, Physical/Chemical Sterilization Process median 87 d · n 59
- KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories median 150 d · n 112
- KGO Surgeon'S Gloves median 171 d · n 72
- KPE Container, I.V. median 200 d · n 14
- LGZ Warmer, Thermal, Infusion Fluid median 209 d · n 13
- LHI Set, I.V. Fluid Transfer median 225 d · n 38
- LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days median 155 d · n 32
- LYY Latex Patient Examination Glove median 143 d · n 30
- LYZ Vinyl Patient Examination Glove median 89 d · n 64
- LZA Polymer Patient Examination Glove median 112 d · n 492
- LZC Medical Glove, Specialty median 109 d · n 28
- MED Sterilant, Medical Devices median 61 d · n 12
- MEG Syringe, Antistick median 225 d · n 33
- MLR Sterilizer, Chemical median 129 d · n 20
- MMK Container, Sharps median 167 d · n 18
- NGT Saline, Vascular Access Flush median 145 d · n 15
- ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System median 197 d · n 31
- QNQ Low Dead Space Piston Syringe median 181 d · n 12
- QPC Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection median 178 d · n 11
General, Plastic Surgery
- BTA Pump, Portable, Aspiration (Manual Or Powered) median 121 d · n 30
- FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature median 81 d · n 57
- FRO Dressing, Wound, Drug median 250 d · n 135
- FTC Light, Ultraviolet, Dermatological median 90 d · n 24
- FTL Mesh, Surgical, Polymeric median 99 d · n 42
- FTM Mesh, Surgical median 89 d · n 23
- FZP Clip, Implantable median 141 d · n 22
- GAG Stapler, Surgical median 119 d · n 11
- GAM Suture, Absorbable, Synthetic, Polyglycolic Acid median 123 d · n 25
- GAT Suture, Nonabsorbable, Synthetic, Polyethylene median 121 d · n 45
- GAW Suture, Nonabsorbable, Synthetic, Polypropylene median 130 d · n 11
- GCJ Laparoscope, General & Plastic Surgery median 99 d · n 208
- GDW Staple, Implantable median 131 d · n 57
- GEH Unit, Cryosurgical, Accessories median 90 d · n 67
- GEI Electrosurgical, Cutting & Coagulation & Accessories median 117 d · n 473
- GEX Powered Laser Surgical Instrument median 90 d · n 526
- JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered median 55 d · n 11
- KGN Wound Dressing With Animal-Derived Material(S) median 171 d · n 77
- KNW Instrument, Biopsy median 132 d · n 68
- LCJ Tissue Expander And Accessories median 122 d · n 10
- LEJ Booth, Sun Tan median 109 d · n 11
- LFL Instrument, Ultrasonic Surgical median 118 d · n 36
- MUD Oximeter, Tissue Saturation median 127 d · n 26
- MUU System, Suction, Lipoplasty median 192 d · n 10
- NAY System, Surgical, Computer Controlled Instrument median 100 d · n 87
- NEU Marker, Radiographic, Implantable median 123 d · n 41
- NEW Suture, Surgical, Absorbable, Polydioxanone median 204 d · n 27
- NEY System, Ablation, Microwave And Accessories median 152 d · n 36
- NQQ System, Imaging, Optical Coherence Tomography (Oct) median 90 d · n 23
- NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed median 95 d · n 12
- OAB Low Energy Direct Current Thermal Ablation System median 187 d · n 10
- OAP Laser, Comb, Hair median 89 d · n 78
- OHS Light Based Over The Counter Wrinkle Reduction median 90 d · n 130
- OHT Light Based Over-The-Counter Hair Removal median 82 d · n 145
- OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption median 89 d · n 17
- OLI Fat Reducing Low Level Laser median 119 d · n 15
- OLP Over-The-Counter Powered Light Based Laser For Acne median 129 d · n 26
- OMP Negative Pressure Wound Therapy Powered Suction Pump median 244 d · n 82
- ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect median 94 d · n 31
- ONG Powered Laser Surgical Instrument With MicrobeamFractional Output median 114 d · n 13
- OWN Confocal Optical Imaging median 82 d · n 40
- PAY Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction median 250 d · n 10
- PBX Massager, Vacuum, Radio Frequency Induced Heat median 180 d · n 59
- PKT Laser For Disruption Of Adipocyte Cells For Aesthetic Use median 92 d · n 14
- QAI Powered Microneedle Device median 165 d · n 25
- QAU Hemostatic Device For Endoscopic Gastrointestinal Use median 195 d · n 11
- QPB System, Suction, Lipoplasty For Removal median 220 d · n 17
- QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature median 85 d · n 17
- QRL Multiple Use Blood Lancet For Single Patient Use Only median 88 d · n 27
- QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics median 242 d · n 28
- QSZ Absorbable Synthetic Wound Dressing median 113 d · n 12
Hematology
- GJS Test, Time, Prothrombin median 168 d · n 14
- GKZ Counter, Differential Cell median 244 d · n 27
- JPA System, Multipurpose For In Vitro Coagulation Studies median 197 d · n 14
- LCP Assay, Glycosylated Hemoglobin median 312 d · n 10
Immunology
- DFH Kappa, Antigen, Antiserum, Control median 236 d · n 14
- DHB System, Test, Radioallergosorbent (Rast) Immunological median 134 d · n 18
- NXO Calprotectin, Fecal median 90 d · n 11
Microbiology
- JSM Culture Media, Non-Propagating Transport median 270 d · n 22
- JTN Susceptibility Test Discs, Antimicrobial median 66 d · n 29
- JWY Manual Antimicrobial Susceptibility Test Systems median 77 d · n 69
- LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation median 90 d · n 50
- LSR Reagent, Borrelia Serological Reagent median 123 d · n 22
- OCC Respiratory Virus Panel Nucleic Acid Assay System median 31 d · n 18
- OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay median 43 d · n 11
- PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System median 104 d · n 24
- PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays median 88 d · n 27
- PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System median 90 d · n 11
- PSZ Devices Detecting Influenza A, B, And C Virus Antigens median 141 d · n 13
- QBD Microbial Nucleic Acid Storage And Stabilization Device median 274 d · n 16
- QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections median 171 d · n 23
- QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents median 178 d · n 35
- QQX Respiratory Specimen Nucleic Acid Sars-Cov-2 Test median 203 d · n 11
- QYT Over-The-Counter Covid-19 Antigen Test median 161 d · n 14
- SCA Multi-Analyte Respiratory Virus Antigen Detection Test median 93 d · n 11
Neurology
- GWF Stimulator, Electrical, Evoked Response median 120 d · n 16
- GWG Endoscope, Neurological median 160 d · n 22
- GWL Amplifier, Physiological Signal median 183 d · n 12
- GWM Device, Monitoring, Intracranial Pressure median 127 d · n 12
- GWN Nystagmograph median 115 d · n 11
- GWO Plate, Cranioplasty, Preformed, Alterable median 170 d · n 13
- GWQ Full-Montage Standard Electroencephalograph median 168 d · n 26
- GXH Device, Surgical, Cryogenic median 56 d · n 10
- GXI Probe, Radiofrequency Lesion median 115 d · n 15
- GXN Plate, Cranioplasty, Preformed, Non-Alterable median 133 d · n 21
- GXY Electrode, Cutaneous median 132 d · n 81
- GYB Media, Electroconductive median 128 d · n 11
- GYC Electrode, Cortical median 208 d · n 11
- GZB Stimulator, Spinal-Cord, Implanted (Pain Relief) median 126 d · n 10
- GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief) median 244 d · n 13
- GZI Stimulator, Neuromuscular, External Functional median 189 d · n 16
- GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief median 161 d · n 23
- GZL Electrode, Depth median 194 d · n 16
- HAE Rongeur, Manual median 210 d · n 10
- HAW Neurological Stereotaxic Instrument median 138 d · n 71
- HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) median 125 d · n 24
- HCG Device, Neurovascular Embolization median 105 d · n 28
- JXG Shunt, Central Nervous System And Components median 103 d · n 34
- JXI Cuff, Nerve median 114 d · n 17
- MOF Guide, Wire, Catheter, Neurovasculature median 163 d · n 33
- NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes median 139 d · n 55
- NRY Catheter, Thrombus Retriever median 129 d · n 79
- NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter median 138 d · n 137
- OBP Transcranial Magnetic Stimulator median 158 d · n 51
- OLT Non-Normalizing Quantitative Electroencephalograph Software median 217 d · n 11
- OLV Standard Polysomnograph With Electroencephalograph median 150 d · n 11
- OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph median 152 d · n 16
- OMB Automatic Event Detection Software For Full-Montage Electroencephalograph median 173 d · n 20
- OMC Reduced- Montage Standard Electroencephalograph median 90 d · n 13
- PCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine median 119 d · n 14
- PDQ Neurosurgical Nerve Locator median 155 d · n 16
- PHL Powered Exoskeleton median 172 d · n 19
- POL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment median 122 d · n 16
- QJP Catheter, Percutaneous, Neurovasculature median 143 d · n 100
Obstetrics/Gynecology
- HEB Tampon, Menstrual, Unscented median 132 d · n 37
- HET Laparoscope, Gynecologic (And Accessories) median 182 d · n 12
- HGM System, Monitoring, Perinatal median 216 d · n 14
- HGX Pump, Breast, Powered median 151 d · n 142
- HHW Pessary, Vaginal median 206 d · n 10
- HIF Insufflator, Laparoscopic median 155 d · n 28
- HIH Hysteroscope (And Accessories) median 136 d · n 55
- HIS Condom median 143 d · n 31
- KNG Monitor, Ultrasonic, Fetal median 202 d · n 13
- LKF Cannula, Manipulator/Injector, Uterine median 145 d · n 14
- MQF Catheter, Assisted Reproduction median 196 d · n 14
- MQK Labware, Assisted Reproduction median 162 d · n 17
- MQL Media, Reproductive median 221 d · n 51
- NUC Lubricant, Personal median 141 d · n 123
Ophthalmic
- HKI Camera, Ophthalmic, Ac-Powered median 135 d · n 34
- HKY Tonometer, Manual median 128 d · n 13
- HQC Unit, Phacofragmentation median 195 d · n 24
- HQD Lens, Contact (Other Material) - Daily median 77 d · n 23
- HQF Laser, Ophthalmic median 110 d · n 30
- LPL Lenses, Soft Contact, Daily Wear median 115 d · n 101
- LPN Accessories, Soft Lens Products median 155 d · n 10
- MSS Folders And Injectors, Intraocular Lens (Iol) median 59 d · n 13
- NFJ System, Image Management, Ophthalmic median 92 d · n 27
- OBO Tomography, Optical Coherence median 157 d · n 36
- OOE Ophthalmic Femtosecond Laser median 118 d · n 15
Orthopedic
- HRS Plate, Fixation, Bone median 90 d · n 416
- HRX Arthroscope median 102 d · n 65
- HSB Rod, Fixation, Intramedullary And Accessories median 134 d · n 125
- HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer median 114 d · n 34
- HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer median 80 d · n 33
- HTN Washer, Bolt Nut median 92 d · n 31
- HTY Pin, Fixation, Smooth median 107 d · n 34
- HWC Screw, Fixation, Bone median 102 d · n 205
- JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented median 185 d · n 25
- JDQ Cerclage, Fixation median 118 d · n 21
- JDR Staple, Fixation, Bone median 84 d · n 43
- JDW Pin, Fixation, Threaded median 76 d · n 11
- JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer median 72 d · n 187
- KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer median 87 d · n 19
- KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component median 92 d · n 62
- KWL Prosthesis, Hip, Hemi-, Femoral, Metal median 55 d · n 11
- KWQ Appliance, Fixation, Spinal Intervertebral Body median 64 d · n 159
- KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented median 128 d · n 37
- KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented median 106 d · n 16
- KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented median 129 d · n 15
- LOD Bone Cement median 117 d · n 21
- LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented median 161 d · n 96
- LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented median 133 d · n 130
- MAI Fastener, Fixation, Biodegradable, Soft Tissue median 78 d · n 73
- MAX Intervertebral Fusion Device With Bone Graft, Lumbar median 106 d · n 388
- MBB Bone Cement, Antibiotic median 116 d · n 10
- MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented median 123 d · n 19
- MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer median 88 d · n 58
- MBI Fastener, Fixation, Nondegradable, Soft Tissue median 74 d · n 248
- MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate median 112 d · n 26
- MQP Spinal Vertebral Body Replacement Device median 121 d · n 26
- MQV Filler, Bone Void, Calcium Compound median 90 d · n 136
- MRW System, Facet Screw Spinal Device median 95 d · n 30
- MTJ Wax, Bone median 70 d · n 10
- NDN Cement, Bone, Vertebroplasty median 98 d · n 21
- NKB Thoracolumbosacral Pedicle Screw System median 68 d · n 342
- NKG Posterior Cervical Screw System median 59 d · n 71
- NQW Orthosis, Spine, Plate, Laminoplasty, Metal median 63 d · n 10
- ODP Intervertebral Fusion Device With Bone Graft, Cervical median 111 d · n 165
- OLO Orthopedic Stereotaxic Instrument median 91 d · n 328
- ONN Intraoperative Orthopedic Joint Assessment Aid median 104 d · n 10
- OUR Sacroiliac Joint Fixation median 88 d · n 98
- OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar median 104 d · n 103
- OVE Intervertebral Fusion Device With Integrated Fixation, Cervical median 92 d · n 90
- OWI Bone Fixation Cerclage, Sublaminar median 74 d · n 16
- PBF Orthopaedic Surgical Planning And Instrument Guides median 218 d · n 24
- PEK Spinous Process Plate median 64 d · n 17
- PHX Shoulder Prosthesis, Reverse Configuration median 139 d · n 109
- PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained median 158 d · n 18
- PLF Bone Wedge median 89 d · n 14
- PLR Spinal Vertebral Body Replacement Device - Cervical median 238 d · n 16
- PML Bone Cement, Posterior Screw Augmentation median 135 d · n 16
- QHE Shoulder Arthroplasty Implantation System median 107 d · n 26
- SBF Orthopedic Augmented Reality median 111 d · n 43
Pathology
- PSY Whole Slide Imaging System median 239 d · n 21
- QKQ Digital Pathology Image Viewing And Management Software median 232 d · n 14
Physical Medicine
- INI Vehicle, Motorized 3-Wheeled median 154 d · n 70
- IOR Wheelchair, Mechanical median 111 d · n 54
- IPF Stimulator, Muscle, Powered median 135 d · n 62
- IPL Wheelchair, Standup median 362 d · n 10
- IRP Massager, Powered Inflatable Tube median 128 d · n 100
- ITI Wheelchair, Powered median 119 d · n 147
- MLY Vapocoolant Device median 148 d · n 10
- NGX Stimulator, Muscle, Powered, For Muscle Conditioning median 164 d · n 92
- NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy median 149 d · n 16
Radiology
- EHD Unit, X-Ray, Extraoral With Timer median 100 d · n 42
- ITX Transducer, Ultrasonic, Diagnostic median 136 d · n 30
- IWB System, Radiation Therapy, Radionuclide median 117 d · n 10
- IYE Accelerator, Linear, Medical median 109 d · n 144
- IYN System, Imaging, Pulsed Doppler, Ultrasonic median 103 d · n 453
- IYO System, Imaging, Pulsed Echo, Ultrasonic median 131 d · n 94
- IZI System, X-Ray, Angiographic median 115 d · n 16
- IZL System, X-Ray, Mobile median 88 d · n 83
- JAA System, X-Ray, Fluoroscopic, Image-Intensified median 62 d · n 28
- JAK System, X-Ray, Tomography, Computed median 132 d · n 231
- JAQ System, Applicator, Radionuclide, Remote-Controlled median 126 d · n 34
- KGI Densitometer, Bone median 238 d · n 10
- KPR System, X-Ray, Stationary median 57 d · n 91
- KPS System, Tomography, Computed, Emission median 60 d · n 89
- KXK Source, Brachytherapy, Radionuclide median 139 d · n 10
- LHN System, Radiation Therapy, Charged-Particle, Medical median 165 d · n 21
- LLZ System, Image Processing, Radiological median 129 d · n 656
- LNH System, Nuclear Magnetic Resonance Imaging median 101 d · n 247
- MOS Coil, Magnetic Resonance, Specialty median 57 d · n 65
- MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) median 36 d · n 138
- MUE Full Field Digital, System, X-Ray, Mammographic median 192 d · n 24
- MUH System, X-Ray, Extraoral Source, Digital median 61 d · n 49
- MUI Media, Coupling, Ultrasound median 211 d · n 13
- MUJ System, Planning, Radiation Therapy Treatment median 123 d · n 81
- MWP Cabinet, X-Ray System median 100 d · n 14
- MYN Analyzer, Medical Image median 215 d · n 40
- OAS X-Ray, Tomography, Computed, Dental median 92 d · n 77
- OEB Lung Computed Tomography System, Computer-Aided Detection median 185 d · n 11
- OWB Interventional Fluoroscopic X-Ray System median 115 d · n 155
- OXO Image-Intensified Fluoroscopic X-Ray System, Mobile median 130 d · n 14
- PGY Display, Diagnostic Radiology median 58 d · n 77
- POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer median 146 d · n 22
- QAS Radiological Computer-Assisted Triage And Notification Software median 104 d · n 87
- QBS Radiological Computer Assisted Detection/Diagnosis Software For Fracture median 181 d · n 10
- QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer median 153 d · n 40
- QFM Radiological Computer-Assisted Prioritization Software For Lesions median 144 d · n 41
- QIH Automated Radiological Image Processing Software median 140 d · n 334
- QKB Radiological Image Processing Software For Radiation Therapy median 145 d · n 49
Source: openFDA 510(k) records, snapshot of 2026-10-06; FDA Recognized Consensus Standards, snapshot of 2026-09-01.