FDA product codes
Every FDA dataset for one product code, on one page.
An FDA product code is the three-letter identifier the agency uses to group devices of the same type, each tied to a device class and a CFR regulation. Each page below joins that code's 510(k) clearances, recall records and MAUDE adverse-event reports, sourced from openFDA with the retrieval time shown beside every figure.
201 codes published · ingest status
All 201 published codes.
| Code | Clearanceslast 12 months | Recall recordsall time | MAUDE reportslast 12 months | What is happening | MAUDE trend |
|---|---|---|---|---|---|
| BSZGas-Machine, AnesthesiaClass II · Anesthesiology | 2189 all time | 173 | 5,788 | Class I recall | 2 months above expected |
| BTMVentilator, Emergency, Manual (Resuscitator)Class II · Anesthesiology | 1209 all time | 97 | 30 | Class I recall | Within expected range |
| BTRTube, Tracheal (W/Wo Connector)Class II · Anesthesiology | 4241 all time | 226 | 1,203 | Worth knowing | 1 month above expected |
| BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Class II · Anesthesiology | 4221 all time | 69 | 2,351 | Class II recall | 4 months above expected |
| BZDVentilator, Non-Continuous (Respirator)Class II · Anesthesiology | 10461 all time | 81 | 27,692 | Worth knowing | 2 months above expected |
| BZGSpirometer, DiagnosticClass II · Anesthesiology | 1228 all time | 1 | 0 | Worth knowing | Within expected range |
| CACApparatus, AutotransfusionClass II · Anesthesiology | 0195 all time | 89 | 75 | Nothing changed | Within expected range |
| CAFNebulizer (Direct Patient Interface)Class II · Anesthesiology | 4508 all time | 36 | 136 | Worth knowing | 1 month above expected |
| CAHFilter, Bacterial, Breathing-CircuitClass II · Anesthesiology | 2202 all time | 28 | 46 | Class I recall | 2 months above expected |
| CAWGenerator, Oxygen, PortableClass II · Anesthesiology | 13287 all time | 44 | 423 | Class II recall | 1 month above expected |
| CBKVentilator, Continuous, Facility UseClass II · Anesthesiology | 6505 all time | 322 | 8,186 | Class I recall | Within expected range |
| CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseClass II · Anesthesiology | 3306 all time | 84 | 751 | Worth knowing | 1 month above expected |
| CGAGlucose Oxidase, GlucoseClass II · Clinical Chemistry | 1401 all time | 89 | 25 | Worth knowing | Within expected range |
| CHHEnzymatic Esterase--Oxidase, CholesterolClass I · Clinical Chemistry | 1230 all time | 23 | 12 | Class II recall | Within expected range |
| CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhClass II · Clinical Chemistry | 1188 all time | 182 | 103 | Serious | 2 months above expected |
| CIGDiazo Colorimetry, BilirubinClass II · Clinical Chemistry | 1235 all time | 19 | 32 | Nothing changed | Within expected range |
| DHBSystem, Test, Radioallergosorbent (Rast) ImmunologicalClass II · Immunology | 6268 all time | 27 | 7 | Class II recall | Within expected range |
| DIFDrug Mixture Control MaterialsClass I · Clinical Toxicology | 0202 all time | 10 | 0 | Nothing changed | No monthly series |
| DJGEnzyme Immunoassay, OpiatesClass II · Clinical Toxicology | 5215 all time | 13 | 1 | Class II recall | Within expected range |
| DKZEnzyme Immunoassay, AmphetamineClass II · Clinical Toxicology | 0225 all time | 24 | 1 | Nothing changed | Within expected range |
| DPSElectrocardiographClass II · Cardiovascular | 4576 all time | 95 | 26 | Class II recall | 1 month above expected |
| DQAOximeterClass II · Cardiovascular | 14726 all time | 128 | 433 | Class II recall | 1 month above expected |
| DQKComputer, Diagnostic, ProgrammableClass II · Cardiovascular | 29435 all time | 124 | 307 | Class II recall | Within expected range |
| DQOCatheter, Intravascular, DiagnosticClass II · Cardiovascular | 3501 all time | 284 | 503 | Class I recall | 2 months above expected |
| DQXWire, Guide, CatheterClass II · Cardiovascular | 13766 all time | 257 | 1,423 | Class I recall | Within expected range |
| DQYCatheter, PercutaneousClass II · Cardiovascular | 11891 all time | 619 | 1,945 | Class I recall | 1 month above expected |
| DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyClass II · Cardiovascular | 3192 all time | 11 | 55 | Worth knowing | Within expected range |
| DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Class II · Cardiovascular | 3339 all time | 11 | 49 | Worth knowing | Within expected range |
| DRXElectrode, ElectrocardiographClass II · Cardiovascular | 0329 all time | 20 | 247 | Nothing changed | 4 months above expected |
| DSHRecorder, Magnetic Tape, MedicalClass II · Cardiovascular | 4195 all time | None | 207 | Worth knowing | 3 months above expected |
| DSIDetector And Alarm, ArrhythmiaClass II · Cardiovascular | 1398 all time | 82 | 273 | Class II recall | Within expected range |
| DSYProsthesis, Vascular Graft, Of 6mm And Greater DiameterClass II · Cardiovascular | 2188 all time | 86 | 95 | Class II recall | 2 months above expected |
| DTBPermanent Pacemaker ElectrodeClass III · Cardiovascular | 0487 all time | 8 | 16,370 | Nothing changed | 1 month above expected |
| DTZOxygenator, Cardiopulmonary BypassClass II · Cardiovascular | 4254 all time | 107 | 892 | Class II recall | 2 months above expected |
| DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassClass II · Cardiovascular | 7401 all time | 560 | 771 | Serious | 1 month above expected |
| DXCClamp, VascularClass II · Cardiovascular | 6205 all time | 26 | 270 | Class II recall | 2 months above expected |
| DXHTransmitters And Receivers, Electrocardiograph, TelephoneClass II · Cardiovascular | 4297 all time | 10 | 27 | Class II recall | Within expected range |
| DXNSystem, Measurement, Blood-Pressure, Non-InvasiveClass II · Cardiovascular | 271,219 all time | 36 | 150 | Worth knowing | Within expected range |
| DXQBlood Pressure CuffClass II · Cardiovascular | 6199 all time | 27 | 17 | Class II recall | Within expected range |
| DXTInjector And Syringe, AngiographicClass II · Cardiovascular | 7210 all time | 69 | 119 | Class I recall | 2 months above expected |
| DXYImplantable Pacemaker Pulse-GeneratorClass III · Cardiovascular | 0461 all time | 75 | 561 | Nothing changed | 1 month above expected |
| DYBIntroducer, CatheterClass II · Cardiovascular | 24705 all time | 388 | 3,634 | Class I recall | 3 months above expected |
| DYHAdhesive, Bracket And Tooth Conditioner, ResinClass II · Dental | 2194 all time | 1 | 1 | Worth knowing | No monthly series |
| DZEImplant, Endosseous, Root-FormClass II · Dental | 271,547 all time | 210 | 297,306 | Worth knowing | 1 month above expected |
| EBFMaterial, Tooth Shade, ResinClass II · Dental | 19934 all time | 69 | 0 | Worth knowing | Within expected range |
| EBGCrown And Bridge, Temporary, ResinClass II · Dental | 2189 all time | 4 | 0 | Worth knowing | No monthly series |
| EBIResin, Denture, Relining, Repairing, RebasingClass II · Dental | 9332 all time | 16 | 1 | Worth knowing | Within expected range |
| EBZActivator, Ultraviolet, For PolymerizationClass II · Dental | 2214 all time | 4 | 2 | Worth knowing | Within expected range |
| EFBHandpiece, Air-Powered, DentalClass I · Dental | 2261 all time | 8 | 44 | Worth knowing | Within expected range |
| EFQGauze/Sponge, InternalClass U · Unknown | 0271 all time | 13 | 18 | Class II recall | Within expected range |
| EHDUnit, X-Ray, Extraoral With TimerClass II · Dental | 6190 all time | 18 | 0 | Worth knowing | Within expected range |
| EIAUnit, Operative DentalClass I · Dental | 1284 all time | 4 | 22 | Nothing changed | Within expected range |
| EIHPowder, PorcelainClass II · Dental | 13485 all time | 35 | 2 | Class II recall | Within expected range |
| EJSAlloy, Other Noble MetalClass II · Dental | 0194 all time | None | 0 | Nothing changed | No monthly series |
| EJTAlloy, Gold-Based Noble MetalClass II · Dental | 0627 all time | None | 0 | Nothing changed | No monthly series |
| ELCScaler, UltrasonicClass II · Dental | 3195 all time | 10 | 204 | Nothing changed | 1 month above expected |
| ELWMaterial, ImpressionClass II · Dental | 2402 all time | 14 | 11 | Worth knowing | Within expected range |
| EMACement, DentalClass II · Dental | 10506 all time | 16 | 3 | Worth knowing | Within expected range |
| EOQBronchoscope (Flexible Or Rigid)Class II · Ear, Nose, Throat | 13241 all time | 160 | 5,883 | Class II recall | 1 month above expected |
| ESDHearing Aid, Air-Conduction, PrescriptionClass I · Ear, Nose, Throat | 01,367 all time | 4 | 37 | Nothing changed | Within expected range |
| EWOAudiometerClass II · Ear, Nose, Throat | 0235 all time | 5 | 10 | Nothing changed | Within expected range |
| FGEStents, Drains And Dilators For The Biliary DuctsClass II · Gastroenterology, Urology | 9475 all time | 448 | 1,265 | Class II recall | Within expected range |
| FLLContinuous Measurement ThermometerClass II · General Hospital | 2798 all time | 18 | 43 | Class II recall | Within expected range |
| FMFSyringe, PistonClass II · General Hospital | 13749 all time | 305 | 2,700 | Class I recall | Within expected range |
| FMINeedle, Hypodermic, Single LumenClass II · General Hospital | 9689 all time | 308 | 1,156 | Worth knowing | Within expected range |
| FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysClass II · General Hospital | 8506 all time | 394 | 3,098 | Class II recall | 1 month above expected |
| FPASet, Administration, IntravascularClass II · General Hospital | 61,174 all time | 1,082 | 24,728 | Class II recall | 1 month above expected |
| FRCIndicator, Biological Sterilization ProcessClass II · General Hospital | 2206 all time | 40 | 6 | Class II recall | Within expected range |
| FRGWrap, SterilizationClass II · General Hospital | 6323 all time | 50 | 24 | Worth knowing | Within expected range |
| FRNPump, InfusionClass II · General Hospital | 2849 all time | 718 | 33,398 | Class I recall | Within expected range |
| FRODressing, Wound, DrugClass U · Unknown | 18705 all time | 82 | 124 | Class II recall | Within expected range |
| FTCLight, Ultraviolet, DermatologicalClass II · General, Plastic Surgery | 2272 all time | 15 | 7 | Class II recall | Within expected range |
| FTLMesh, Surgical, PolymericClass II · General, Plastic Surgery | 2336 all time | 73 | 2,001 | Worth knowing | Within expected range |
| FXXMask, SurgicalClass II · General, Plastic Surgery | 9607 all time | 12 | 14 | Worth knowing | Within expected range |
| FYAGown, SurgicalClass II · General, Plastic Surgery | 8296 all time | 129 | 8 | Class II recall | Within expected range |
| GCJLaparoscope, General & Plastic SurgeryClass II · Gastroenterology, Urology | 301,426 all time | 274 | 4,416 | Class II recall | 1 month above expected |
| GDWStaple, ImplantableClass II · General, Plastic Surgery | 3283 all time | 225 | 7,515 | Class II recall | Within expected range |
| GEHUnit, Cryosurgical, AccessoriesClass II · General, Plastic Surgery | 12263 all time | 105 | 161 | Class I recall | 2 months above expected |
| GEIElectrosurgical, Cutting & Coagulation & AccessoriesClass II · General, Plastic Surgery | 592,312 all time | 643 | 4,957 | Class II recall | 1 month above expected |
| GEXPowered Laser Surgical InstrumentClass II · General, Plastic Surgery | 732,872 all time | 200 | 1,755 | Class II recall | 1 month above expected |
| GGPTest, Qualitative And Quantitative Factor DeficiencyClass II · Hematology | 1190 all time | 13 | 2 | Class II recall | Within expected range |
| GKZCounter, Differential CellClass II · Hematology | 3380 all time | 244 | 43 | Class II recall | Within expected range |
| GWQFull-Montage Standard ElectroencephalographClass II · Neurology | 2189 all time | 23 | 17 | Class II recall | Within expected range |
| GXYElectrode, CutaneousClass II · Neurology | 12439 all time | 20 | 46 | Worth knowing | Within expected range |
| GZJStimulator, Nerve, Transcutaneous, For Pain ReliefClass II · Neurology | 3606 all time | 7 | 7 | Worth knowing | Within expected range |
| HAWNeurological Stereotaxic InstrumentClass II · Neurology | 5423 all time | 197 | 1,358 | Class II recall | 1 month above expected |
| HEBTampon, Menstrual, UnscentedClass II · Obstetrics/Gynecology | 5189 all time | 36 | 300 | Class II recall | 1 month above expected |
| HETLaparoscope, Gynecologic (And Accessories)Class II · Obstetrics/Gynecology | 1338 all time | 19 | 3,269 | Nothing changed | 1 month above expected |
| HGMSystem, Monitoring, PerinatalClass II · Obstetrics/Gynecology | 3214 all time | 28 | 84 | Class II recall | Within expected range |
| HGXPump, Breast, PoweredClass II · Obstetrics/Gynecology | 43248 all time | 8 | 21 | Worth knowing | Within expected range |
| HISCondomClass II · Obstetrics/Gynecology | 2401 all time | 7 | 14 | Class II recall | Within expected range |
| HQCUnit, PhacofragmentationClass II · Ophthalmic | 3316 all time | 74 | 1,190 | Worth knowing | 1 month above expected |
| HQYSunglasses (Non-Prescription Including Photosensitive)Class I · Ophthalmic | 0646 all time | 1 | 0 | Nothing changed | Within expected range |
| HQZFrame, SpectacleClass I · Ophthalmic | 0198 all time | 1 | 0 | Nothing changed | No monthly series |
| HRSPlate, Fixation, BoneClass II · Orthopedic | 591,319 all time | 286 | 1,502 | Class II recall | Within expected range |
| HRXArthroscopeClass II · Orthopedic | 10681 all time | 126 | 1,266 | Worth knowing | Within expected range |
| HSBRod, Fixation, Intramedullary And AccessoriesClass II · Orthopedic | 22530 all time | 690 | 1,777 | Class II recall | 1 month above expected |
| HTYPin, Fixation, SmoothClass II · Orthopedic | 2204 all time | 31 | 34 | Worth knowing | Within expected range |
| HWCScrew, Fixation, BoneClass II · Orthopedic | 201,061 all time | 388 | 1,843 | Class II recall | 1 month above expected |
| ILYLamp, Infrared, Therapeutic HeatingClass II · Physical Medicine | 1229 all time | 20 | 15 | Class II recall | Within expected range |
| INIVehicle, Motorized 3-WheeledClass II · Physical Medicine | 20349 all time | 22 | 17 | Worth knowing | Within expected range |
| IORWheelchair, MechanicalClass I · Physical Medicine | 16462 all time | 40 | 42 | Worth knowing | Within expected range |
| IPFStimulator, Muscle, PoweredClass II · Physical Medicine | 4548 all time | 7 | 9 | Worth knowing | Within expected range |
| ITIWheelchair, PoweredClass II · Physical Medicine | 34585 all time | 71 | 754 | Serious | 5 months above expected |
| ITXTransducer, Ultrasonic, DiagnosticClass II · Radiology | 2410 all time | 147 | 362 | Class II recall | Within expected range |
| IYEAccelerator, Linear, MedicalClass II · Radiology | 16734 all time | 562 | 37 | Class II recall | 2 months above expected |
| IYNSystem, Imaging, Pulsed Doppler, UltrasonicClass II · Radiology | 531,175 all time | 298 | 401 | Class II recall | 2 months above expected |
| IYOSystem, Imaging, Pulsed Echo, UltrasonicClass II · Radiology | 8894 all time | 82 | 218 | Class II recall | Within expected range |
| IZISystem, X-Ray, AngiographicClass II · Radiology | 3199 all time | 259 | 1,487 | Class II recall | 2 months above expected |
| IZLSystem, X-Ray, MobileClass II · Radiology | 8236 all time | 170 | 17 | Class II recall | Within expected range |
| JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedClass II · Radiology | 2300 all time | 223 | 19 | Class II recall | Within expected range |
| JAKSystem, X-Ray, Tomography, ComputedClass II · Radiology | 22821 all time | 860 | 130 | Class II recall | Within expected range |
| JAQSystem, Applicator, Radionuclide, Remote-ControlledClass II · Radiology | 4208 all time | 52 | 6 | Class II recall | Within expected range |
| JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedClass II · Orthopedic | 2564 all time | 255 | 1,023 | Class II recall | 1 month above expected |
| JDRStaple, Fixation, BoneClass II · Orthopedic | 0231 all time | 36 | 240 | Class II recall | 2 months above expected |
| JEYPlate, BoneClass II · Dental | 4293 all time | 111 | 619 | Worth knowing | 2 months above expected |
| JHIVisual, Pregnancy Hcg, Prescription UseClass II · Clinical Chemistry | 0375 all time | 43 | 122 | Nothing changed | 1 month above expected |
| JITCalibrator, SecondaryClass II · Clinical Chemistry | 0245 all time | 55 | 0 | Serious | Within expected range |
| JIXCalibrator, Multi-Analyte MixtureClass II · Clinical Chemistry | 0302 all time | 73 | 8 | Serious | Within expected range |
| JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClass I · Clinical Chemistry | 0208 all time | 559 | 2,968 | Class II recall | 1 month above expected |
| JJQColorimeter, Photometer, Spectrophotometer For Clinical UseClass I · Clinical Chemistry | 0258 all time | 17 | 15 | Class II recall | Within expected range |
| JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Class I · Clinical Chemistry | 0493 all time | 42 | 14 | Nothing changed | Within expected range |
| JJYMulti-Analyte Controls, All Kinds (Assayed)Class I · Clinical Chemistry | 0673 all time | 91 | 3 | Class II recall | Within expected range |
| JKATubes, Vials, Systems, Serum Separators, Blood CollectionClass II · Clinical Chemistry | 6236 all time | 170 | 4,071 | Class II recall | 1 month above expected |
| JLWRadioimmunoassay, Thyroid-Stimulating HormoneClass II · Clinical Chemistry | 1242 all time | 46 | 62 | Class II recall | 1 month above expected |
| JOJIndicator, Physical/Chemical Sterilization ProcessClass II · General Hospital | 2264 all time | 24 | 14 | Worth knowing | Within expected range |
| JOWSleeve, Limb, CompressibleClass II · Cardiovascular | 8351 all time | 32 | 23 | Worth knowing | Within expected range |
| JPKMixture, Hematology Quality ControlClass II · Hematology | 0192 all time | 16 | 0 | Nothing changed | No monthly series |
| JSGCulture Media, Non-Selective And Non-DifferentialClass I · Microbiology | 0209 all time | 29 | 97 | Nothing changed | Within expected range |
| JSICulture Media, Selective And DifferentialClass I · Microbiology | 0285 all time | 24 | 38 | Nothing changed | Within expected range |
| JSJCulture Media, Selective And Non-DifferentialClass I · Microbiology | 0307 all time | 6 | 75 | Class II recall | Within expected range |
| JTNSusceptibility Test Discs, AntimicrobialClass II · Microbiology | 6330 all time | 47 | 4 | Serious | Within expected range |
| JTODiscs, Strips And Reagents, Microorganism DifferentiationClass I · Microbiology | 0244 all time | 21 | 0 | Nothing changed | Within expected range |
| JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerClass II · Orthopedic | 9913 all time | 983 | 5,080 | Class II recall | Within expected range |
| JWYManual Antimicrobial Susceptibility Test SystemsClass II · Microbiology | 7441 all time | 78 | 0 | Nothing changed | Within expected range |
| JXGShunt, Central Nervous System And ComponentsClass II · Neurology | 4259 all time | 108 | 783 | Class II recall | 1 month above expected |
| KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesClass II · General Hospital | 6280 all time | 38 | 19 | Worth knowing | Within expected range |
| KDIDialyzer, High Permeability With Or Without Sealed Dialysate SystemClass II · Gastroenterology, Urology | 7345 all time | 216 | 1,857 | Class II recall | 2 months above expected |
| KGNWound Dressing With Animal-Derived Material(S)Class U · Unknown | 17190 all time | 23 | 8 | Class II recall | Within expected range |
| KGOSurgeon'S GlovesClass I · General, Plastic Surgery | 2559 all time | 44 | 29 | Class I recall | Within expected range |
| KGXTape And Bandage, AdhesiveClass I · General Hospital | 0187 all time | 48 | 250 | Class II recall | 3 months above expected |
| KITMedia And Components, Synthetic Cell And Tissue CultureClass I · Hematology | 0367 all time | 4 | 0 | Nothing changed | No monthly series |
| KKXDrape, Surgical, AntimicrobialClass II · General, Plastic Surgery | 0450 all time | 91 | 9 | Class II recall | Within expected range |
| KLEAgent, Tooth Bonding, ResinClass II · Dental | 8419 all time | 20 | 13 | Worth knowing | Within expected range |
| KMFBandage, LiquidClass I · General Hospital | 0222 all time | 4 | 8 | Nothing changed | Within expected range |
| KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Class II · Gastroenterology, Urology | 6188 all time | 121 | 1,228 | Class II recall | 1 month above expected |
| KNTTubes, Gastrointestinal (And Accessories)Class II · Gastroenterology, Urology | 1650 all time | 268 | 1,011 | Class II recall | 1 month above expected |
| KNWInstrument, BiopsyClass II · Gastroenterology, Urology | 5361 all time | 106 | 1,629 | Class I recall | 3 months above expected |
| KNXCollector, Urine, (And Accessories) For Indwelling CatheterClass II · Gastroenterology, Urology | 0206 all time | 19 | 119 | Nothing changed | Within expected range |
| KODCatheter, UrologicalClass II · Gastroenterology, Urology | 1238 all time | 107 | 668 | Nothing changed | 1 month above expected |
| KPRSystem, X-Ray, StationaryClass II · Radiology | 6356 all time | 168 | 32 | Class II recall | 1 month above expected |
| KPSSystem, Tomography, Computed, EmissionClass II · Radiology | 9471 all time | 443 | 7 | Class II recall | 1 month above expected |
| KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentClass II · Orthopedic | 10404 all time | 89 | 285 | Serious | 1 month above expected |
| KWPAppliance, Fixation, Spinal InterlaminalClass II · Orthopedic | 0430 all time | 68 | 309 | Nothing changed | 1 month above expected |
| KWQAppliance, Fixation, Spinal Intervertebral BodyClass II · Orthopedic | 11667 all time | 214 | 177 | Class II recall | 1 month above expected |
| KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedClass II · Orthopedic | 4191 all time | 152 | 1,501 | Class II recall | 1 month above expected |
| LCPAssay, Glycosylated HemoglobinClass II · Hematology | 0249 all time | 103 | 47 | Class II recall | Within expected range |
| LCXKit, Test, Pregnancy, Hcg, Over The CounterClass II · Clinical Chemistry | 1226 all time | 25 | 0 | Class II recall | Within expected range |
| LHISet, I.V. Fluid TransferClass II · General Hospital | 5206 all time | 61 | 1,096 | Worth knowing | 1 month above expected |
| LITCatheter, Angioplasty, Peripheral, TransluminalClass II · Cardiovascular | 3403 all time | 32 | 1,405 | Class II recall | Within expected range |
| LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysClass II · General Hospital | 3302 all time | 332 | 2,431 | Class II recall | Within expected range |
| LJTPort & Catheter, Implanted, Subcutaneous, IntravascularClass II · General Hospital | 2288 all time | 141 | 3,166 | Class I recall | 3 months above expected |
| LLZSystem, Image Processing, RadiologicalClass II · Radiology | 522,281 all time | 552 | 179 | Class II recall | 2 months above expected |
| LNHSystem, Nuclear Magnetic Resonance ImagingClass II · Radiology | 221,099 all time | 699 | 356 | Class II recall | 1 month above expected |
| LONSystem, Test, Automated, Antimicrobial Susceptibility, Short IncubationClass II · Microbiology | 3289 all time | 237 | 671 | Class II recall | 1 month above expected |
| LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedClass II · Orthopedic | 9562 all time | 297 | 3,872 | Class II recall | 2 months above expected |
| LPLLenses, Soft Contact, Daily WearClass II · Ophthalmic | 12486 all time | 70 | 132 | Class II recall | Within expected range |
| LRKDevice, Anti-SnoringClass II · Dental | 18213 all time | 10 | 643 | Class II recall | 2 months above expected |
| LYCBone Grafting Material, SyntheticClass II · Dental | 5231 all time | 14 | 1 | Worth knowing | Within expected range |
| LYYLatex Patient Examination GloveClass I · General Hospital | 01,954 all time | 6 | 1 | Nothing changed | Within expected range |
| LYZVinyl Patient Examination GloveClass I · General Hospital | 3799 all time | 7 | 0 | Worth knowing | Within expected range |
| LZAPolymer Patient Examination GloveClass I · General Hospital | 151,175 all time | 7 | 56 | Worth knowing | Within expected range |
| LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedClass II · Orthopedic | 7532 all time | 177 | 1,888 | Class II recall | 1 month above expected |
| MAIFastener, Fixation, Biodegradable, Soft TissueClass II · Orthopedic | 6220 all time | 96 | 1,639 | Class II recall | 2 months above expected |
| MAXIntervertebral Fusion Device With Bone Graft, LumbarClass II · Orthopedic | 22894 all time | 115 | 465 | Class II recall | Within expected range |
| MBIFastener, Fixation, Nondegradable, Soft TissueClass II · Orthopedic | 28597 all time | 113 | 2,668 | Class II recall | Within expected range |
| MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Class II · Cardiovascular | 13426 all time | 282 | 2,949 | Class II recall | 2 months above expected |
| MKJAutomated External Defibrillators (Non-Wearable)Class III · Cardiovascular | 0228 all time | 334 | 8,580 | Class II recall | Within expected range |
| MNHOrthosis, Spondylolisthesis Spinal FixationClass II · Orthopedic | 0309 all time | 15 | 49 | Nothing changed | Within expected range |
| MNIOrthosis, Spinal Pedicle FixationClass II · Orthopedic | 0303 all time | 213 | 36 | Class II recall | 1 month above expected |
| MOSCoil, Magnetic Resonance, SpecialtyClass II · Radiology | 9489 all time | 38 | 1 | Nothing changed | Within expected range |
| MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Class II · Radiology | 3423 all time | 195 | 55 | Class II recall | 1 month above expected |
| MQLMedia, ReproductiveClass II · Obstetrics/Gynecology | 5259 all time | 15 | 2 | Nothing changed | Within expected range |
| MQPSpinal Vertebral Body Replacement DeviceClass II · Orthopedic | 2278 all time | 46 | 108 | Serious | 2 months above expected |
| MQVFiller, Bone Void, Calcium CompoundClass II · Orthopedic | 7492 all time | 120 | 41 | Class II recall | Within expected range |
| MUHSystem, X-Ray, Extraoral Source, DigitalClass II · Dental | 4206 all time | 9 | 0 | Worth knowing | Within expected range |
| MUJSystem, Planning, Radiation Therapy TreatmentClass II · Radiology | 13257 all time | 267 | 12 | Class II recall | Within expected range |
| MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Class II · Cardiovascular | 4306 all time | 77 | 199 | Class II recall | 1 month above expected |
| NBWSystem, Test, Blood Glucose, Over The CounterClass II · Clinical Chemistry | 2509 all time | 137 | 3,029 | Class I recall | Within expected range |
| NHAAbutment, Implant, Dental, EndosseousClass II · Dental | 37712 all time | 224 | 863 | Class II recall | 3 months above expected |
| NKBThoracolumbosacral Pedicle Screw SystemClass II · Orthopedic | 31905 all time | 181 | 816 | Class II recall | Within expected range |
| NUCLubricant, PersonalClass II · Obstetrics/Gynecology | 13246 all time | 7 | 7 | Worth knowing | Within expected range |
| NUHStimulator, Nerve, Transcutaneous, Over-The-CounterClass II · Neurology | 11229 all time | None | 5 | Worth knowing | Within expected range |
| ODPIntervertebral Fusion Device With Bone Graft, CervicalClass II · Orthopedic | 24352 all time | 11 | 38 | Class III recall | Within expected range |
| OLOOrthopedic Stereotaxic InstrumentClass II · Neurology | 51437 all time | 112 | 1,908 | Class II recall | 1 month above expected |
| OMPNegative Pressure Wound Therapy Powered Suction PumpClass II · General, Plastic Surgery | 9214 all time | 47 | 72 | Worth knowing | 1 month above expected |
| OVDIntervertebral Fusion Device With Integrated Fixation, LumbarClass II · Orthopedic | 7202 all time | 36 | 36 | Class II recall | Within expected range |
| OWBInterventional Fluoroscopic X-Ray SystemClass II · Radiology | 17321 all time | 620 | 8,971 | Class II recall | 4 months above expected |
| PHXShoulder Prosthesis, Reverse ConfigurationClass II · Orthopedic | 20205 all time | 67 | 1,992 | Class II recall | 2 months above expected |
| QASRadiological Computer-Assisted Triage And Notification SoftwareClass II · Radiology | 1686 all time | None | 0 | Worth knowing | No monthly series |
| QIHAutomated Radiological Image Processing SoftwareClass II · Radiology | 93314 all time | 2 | 64 | Class II recall | Within expected range |
Data from FDA's public openFDA API, US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration.