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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.

Published FDA product codes. Sortable by any numbered column; MAUDE trend is the monthly adverse-event count over the code's recorded history, oldest month on the left.
CodeClearanceslast 12 monthsRecall recordsall timeMAUDE reportslast 12 monthsWhat is happeningMAUDE trend
BSZGas-Machine, AnesthesiaClass II · Anesthesiology2189 all time1735,788Class I recall2 months above expected
BTMVentilator, Emergency, Manual (Resuscitator)Class II · Anesthesiology1209 all time9730Class I recallWithin expected range
BTRTube, Tracheal (W/Wo Connector)Class II · Anesthesiology4241 all time2261,203Worth knowing1 month above expected
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Class II · Anesthesiology4221 all time692,351Class II recall4 months above expected
BZDVentilator, Non-Continuous (Respirator)Class II · Anesthesiology10461 all time8127,692Worth knowing2 months above expected
BZGSpirometer, DiagnosticClass II · Anesthesiology1228 all time10Worth knowingWithin expected range
CACApparatus, AutotransfusionClass II · Anesthesiology0195 all time8975Nothing changedWithin expected range
CAFNebulizer (Direct Patient Interface)Class II · Anesthesiology4508 all time36136Worth knowing1 month above expected
CAHFilter, Bacterial, Breathing-CircuitClass II · Anesthesiology2202 all time2846Class I recall2 months above expected
CAWGenerator, Oxygen, PortableClass II · Anesthesiology13287 all time44423Class II recall1 month above expected
CBKVentilator, Continuous, Facility UseClass II · Anesthesiology6505 all time3228,186Class I recallWithin expected range
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseClass II · Anesthesiology3306 all time84751Worth knowing1 month above expected
CGAGlucose Oxidase, GlucoseClass II · Clinical Chemistry1401 all time8925Worth knowingWithin expected range
CHHEnzymatic Esterase--Oxidase, CholesterolClass I · Clinical Chemistry1230 all time2312Class II recallWithin expected range
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhClass II · Clinical Chemistry1188 all time182103Serious2 months above expected
CIGDiazo Colorimetry, BilirubinClass II · Clinical Chemistry1235 all time1932Nothing changedWithin expected range
DHBSystem, Test, Radioallergosorbent (Rast) ImmunologicalClass II · Immunology6268 all time277Class II recallWithin expected range
DIFDrug Mixture Control MaterialsClass I · Clinical Toxicology0202 all time100Nothing changedNo monthly series
DJGEnzyme Immunoassay, OpiatesClass II · Clinical Toxicology5215 all time131Class II recallWithin expected range
DKZEnzyme Immunoassay, AmphetamineClass II · Clinical Toxicology0225 all time241Nothing changedWithin expected range
DPSElectrocardiographClass II · Cardiovascular4576 all time9526Class II recall1 month above expected
DQAOximeterClass II · Cardiovascular14726 all time128433Class II recall1 month above expected
DQKComputer, Diagnostic, ProgrammableClass II · Cardiovascular29435 all time124307Class II recallWithin expected range
DQOCatheter, Intravascular, DiagnosticClass II · Cardiovascular3501 all time284503Class I recall2 months above expected
DQXWire, Guide, CatheterClass II · Cardiovascular13766 all time2571,423Class I recallWithin expected range
DQYCatheter, PercutaneousClass II · Cardiovascular11891 all time6191,945Class I recall1 month above expected
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyClass II · Cardiovascular3192 all time1155Worth knowingWithin expected range
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Class II · Cardiovascular3339 all time1149Worth knowingWithin expected range
DRXElectrode, ElectrocardiographClass II · Cardiovascular0329 all time20247Nothing changed4 months above expected
DSHRecorder, Magnetic Tape, MedicalClass II · Cardiovascular4195 all timeNone207Worth knowing3 months above expected
DSIDetector And Alarm, ArrhythmiaClass II · Cardiovascular1398 all time82273Class II recallWithin expected range
DSYProsthesis, Vascular Graft, Of 6mm And Greater DiameterClass II · Cardiovascular2188 all time8695Class II recall2 months above expected
DTBPermanent Pacemaker ElectrodeClass III · Cardiovascular0487 all time816,370Nothing changed1 month above expected
DTZOxygenator, Cardiopulmonary BypassClass II · Cardiovascular4254 all time107892Class II recall2 months above expected
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassClass II · Cardiovascular7401 all time560771Serious1 month above expected
DXCClamp, VascularClass II · Cardiovascular6205 all time26270Class II recall2 months above expected
DXHTransmitters And Receivers, Electrocardiograph, TelephoneClass II · Cardiovascular4297 all time1027Class II recallWithin expected range
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveClass II · Cardiovascular271,219 all time36150Worth knowingWithin expected range
DXQBlood Pressure CuffClass II · Cardiovascular6199 all time2717Class II recallWithin expected range
DXTInjector And Syringe, AngiographicClass II · Cardiovascular7210 all time69119Class I recall2 months above expected
DXYImplantable Pacemaker Pulse-GeneratorClass III · Cardiovascular0461 all time75561Nothing changed1 month above expected
DYBIntroducer, CatheterClass II · Cardiovascular24705 all time3883,634Class I recall3 months above expected
DYHAdhesive, Bracket And Tooth Conditioner, ResinClass II · Dental2194 all time11Worth knowingNo monthly series
DZEImplant, Endosseous, Root-FormClass II · Dental271,547 all time210297,306Worth knowing1 month above expected
EBFMaterial, Tooth Shade, ResinClass II · Dental19934 all time690Worth knowingWithin expected range
EBGCrown And Bridge, Temporary, ResinClass II · Dental2189 all time40Worth knowingNo monthly series
EBIResin, Denture, Relining, Repairing, RebasingClass II · Dental9332 all time161Worth knowingWithin expected range
EBZActivator, Ultraviolet, For PolymerizationClass II · Dental2214 all time42Worth knowingWithin expected range
EFBHandpiece, Air-Powered, DentalClass I · Dental2261 all time844Worth knowingWithin expected range
EFQGauze/Sponge, InternalClass U · Unknown0271 all time1318Class II recallWithin expected range
EHDUnit, X-Ray, Extraoral With TimerClass II · Dental6190 all time180Worth knowingWithin expected range
EIAUnit, Operative DentalClass I · Dental1284 all time422Nothing changedWithin expected range
EIHPowder, PorcelainClass II · Dental13485 all time352Class II recallWithin expected range
EJSAlloy, Other Noble MetalClass II · Dental0194 all timeNone0Nothing changedNo monthly series
EJTAlloy, Gold-Based Noble MetalClass II · Dental0627 all timeNone0Nothing changedNo monthly series
ELCScaler, UltrasonicClass II · Dental3195 all time10204Nothing changed1 month above expected
ELWMaterial, ImpressionClass II · Dental2402 all time1411Worth knowingWithin expected range
EMACement, DentalClass II · Dental10506 all time163Worth knowingWithin expected range
EOQBronchoscope (Flexible Or Rigid)Class II · Ear, Nose, Throat13241 all time1605,883Class II recall1 month above expected
ESDHearing Aid, Air-Conduction, PrescriptionClass I · Ear, Nose, Throat01,367 all time437Nothing changedWithin expected range
EWOAudiometerClass II · Ear, Nose, Throat0235 all time510Nothing changedWithin expected range
FGEStents, Drains And Dilators For The Biliary DuctsClass II · Gastroenterology, Urology9475 all time4481,265Class II recallWithin expected range
FLLContinuous Measurement ThermometerClass II · General Hospital2798 all time1843Class II recallWithin expected range
FMFSyringe, PistonClass II · General Hospital13749 all time3052,700Class I recallWithin expected range
FMINeedle, Hypodermic, Single LumenClass II · General Hospital9689 all time3081,156Worth knowingWithin expected range
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysClass II · General Hospital8506 all time3943,098Class II recall1 month above expected
FPASet, Administration, IntravascularClass II · General Hospital61,174 all time1,08224,728Class II recall1 month above expected
FRCIndicator, Biological Sterilization ProcessClass II · General Hospital2206 all time406Class II recallWithin expected range
FRGWrap, SterilizationClass II · General Hospital6323 all time5024Worth knowingWithin expected range
FRNPump, InfusionClass II · General Hospital2849 all time71833,398Class I recallWithin expected range
FRODressing, Wound, DrugClass U · Unknown18705 all time82124Class II recallWithin expected range
FTCLight, Ultraviolet, DermatologicalClass II · General, Plastic Surgery2272 all time157Class II recallWithin expected range
FTLMesh, Surgical, PolymericClass II · General, Plastic Surgery2336 all time732,001Worth knowingWithin expected range
FXXMask, SurgicalClass II · General, Plastic Surgery9607 all time1214Worth knowingWithin expected range
FYAGown, SurgicalClass II · General, Plastic Surgery8296 all time1298Class II recallWithin expected range
GCJLaparoscope, General & Plastic SurgeryClass II · Gastroenterology, Urology301,426 all time2744,416Class II recall1 month above expected
GDWStaple, ImplantableClass II · General, Plastic Surgery3283 all time2257,515Class II recallWithin expected range
GEHUnit, Cryosurgical, AccessoriesClass II · General, Plastic Surgery12263 all time105161Class I recall2 months above expected
GEIElectrosurgical, Cutting & Coagulation & AccessoriesClass II · General, Plastic Surgery592,312 all time6434,957Class II recall1 month above expected
GEXPowered Laser Surgical InstrumentClass II · General, Plastic Surgery732,872 all time2001,755Class II recall1 month above expected
GGPTest, Qualitative And Quantitative Factor DeficiencyClass II · Hematology1190 all time132Class II recallWithin expected range
GKZCounter, Differential CellClass II · Hematology3380 all time24443Class II recallWithin expected range
GWQFull-Montage Standard ElectroencephalographClass II · Neurology2189 all time2317Class II recallWithin expected range
GXYElectrode, CutaneousClass II · Neurology12439 all time2046Worth knowingWithin expected range
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefClass II · Neurology3606 all time77Worth knowingWithin expected range
HAWNeurological Stereotaxic InstrumentClass II · Neurology5423 all time1971,358Class II recall1 month above expected
HEBTampon, Menstrual, UnscentedClass II · Obstetrics/Gynecology5189 all time36300Class II recall1 month above expected
HETLaparoscope, Gynecologic (And Accessories)Class II · Obstetrics/Gynecology1338 all time193,269Nothing changed1 month above expected
HGMSystem, Monitoring, PerinatalClass II · Obstetrics/Gynecology3214 all time2884Class II recallWithin expected range
HGXPump, Breast, PoweredClass II · Obstetrics/Gynecology43248 all time821Worth knowingWithin expected range
HISCondomClass II · Obstetrics/Gynecology2401 all time714Class II recallWithin expected range
HQCUnit, PhacofragmentationClass II · Ophthalmic3316 all time741,190Worth knowing1 month above expected
HQYSunglasses (Non-Prescription Including Photosensitive)Class I · Ophthalmic0646 all time10Nothing changedWithin expected range
HQZFrame, SpectacleClass I · Ophthalmic0198 all time10Nothing changedNo monthly series
HRSPlate, Fixation, BoneClass II · Orthopedic591,319 all time2861,502Class II recallWithin expected range
HRXArthroscopeClass II · Orthopedic10681 all time1261,266Worth knowingWithin expected range
HSBRod, Fixation, Intramedullary And AccessoriesClass II · Orthopedic22530 all time6901,777Class II recall1 month above expected
HTYPin, Fixation, SmoothClass II · Orthopedic2204 all time3134Worth knowingWithin expected range
HWCScrew, Fixation, BoneClass II · Orthopedic201,061 all time3881,843Class II recall1 month above expected
ILYLamp, Infrared, Therapeutic HeatingClass II · Physical Medicine1229 all time2015Class II recallWithin expected range
INIVehicle, Motorized 3-WheeledClass II · Physical Medicine20349 all time2217Worth knowingWithin expected range
IORWheelchair, MechanicalClass I · Physical Medicine16462 all time4042Worth knowingWithin expected range
IPFStimulator, Muscle, PoweredClass II · Physical Medicine4548 all time79Worth knowingWithin expected range
ITIWheelchair, PoweredClass II · Physical Medicine34585 all time71754Serious5 months above expected
ITXTransducer, Ultrasonic, DiagnosticClass II · Radiology2410 all time147362Class II recallWithin expected range
IYEAccelerator, Linear, MedicalClass II · Radiology16734 all time56237Class II recall2 months above expected
IYNSystem, Imaging, Pulsed Doppler, UltrasonicClass II · Radiology531,175 all time298401Class II recall2 months above expected
IYOSystem, Imaging, Pulsed Echo, UltrasonicClass II · Radiology8894 all time82218Class II recallWithin expected range
IZISystem, X-Ray, AngiographicClass II · Radiology3199 all time2591,487Class II recall2 months above expected
IZLSystem, X-Ray, MobileClass II · Radiology8236 all time17017Class II recallWithin expected range
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedClass II · Radiology2300 all time22319Class II recallWithin expected range
JAKSystem, X-Ray, Tomography, ComputedClass II · Radiology22821 all time860130Class II recallWithin expected range
JAQSystem, Applicator, Radionuclide, Remote-ControlledClass II · Radiology4208 all time526Class II recallWithin expected range
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedClass II · Orthopedic2564 all time2551,023Class II recall1 month above expected
JDRStaple, Fixation, BoneClass II · Orthopedic0231 all time36240Class II recall2 months above expected
JEYPlate, BoneClass II · Dental4293 all time111619Worth knowing2 months above expected
JHIVisual, Pregnancy Hcg, Prescription UseClass II · Clinical Chemistry0375 all time43122Nothing changed1 month above expected
JITCalibrator, SecondaryClass II · Clinical Chemistry0245 all time550SeriousWithin expected range
JIXCalibrator, Multi-Analyte MixtureClass II · Clinical Chemistry0302 all time738SeriousWithin expected range
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClass I · Clinical Chemistry0208 all time5592,968Class II recall1 month above expected
JJQColorimeter, Photometer, Spectrophotometer For Clinical UseClass I · Clinical Chemistry0258 all time1715Class II recallWithin expected range
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Class I · Clinical Chemistry0493 all time4214Nothing changedWithin expected range
JJYMulti-Analyte Controls, All Kinds (Assayed)Class I · Clinical Chemistry0673 all time913Class II recallWithin expected range
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClass II · Clinical Chemistry6236 all time1704,071Class II recall1 month above expected
JLWRadioimmunoassay, Thyroid-Stimulating HormoneClass II · Clinical Chemistry1242 all time4662Class II recall1 month above expected
JOJIndicator, Physical/Chemical Sterilization ProcessClass II · General Hospital2264 all time2414Worth knowingWithin expected range
JOWSleeve, Limb, CompressibleClass II · Cardiovascular8351 all time3223Worth knowingWithin expected range
JPKMixture, Hematology Quality ControlClass II · Hematology0192 all time160Nothing changedNo monthly series
JSGCulture Media, Non-Selective And Non-DifferentialClass I · Microbiology0209 all time2997Nothing changedWithin expected range
JSICulture Media, Selective And DifferentialClass I · Microbiology0285 all time2438Nothing changedWithin expected range
JSJCulture Media, Selective And Non-DifferentialClass I · Microbiology0307 all time675Class II recallWithin expected range
JTNSusceptibility Test Discs, AntimicrobialClass II · Microbiology6330 all time474SeriousWithin expected range
JTODiscs, Strips And Reagents, Microorganism DifferentiationClass I · Microbiology0244 all time210Nothing changedWithin expected range
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerClass II · Orthopedic9913 all time9835,080Class II recallWithin expected range
JWYManual Antimicrobial Susceptibility Test SystemsClass II · Microbiology7441 all time780Nothing changedWithin expected range
JXGShunt, Central Nervous System And ComponentsClass II · Neurology4259 all time108783Class II recall1 month above expected
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesClass II · General Hospital6280 all time3819Worth knowingWithin expected range
KDIDialyzer, High Permeability With Or Without Sealed Dialysate SystemClass II · Gastroenterology, Urology7345 all time2161,857Class II recall2 months above expected
KGNWound Dressing With Animal-Derived Material(S)Class U · Unknown17190 all time238Class II recallWithin expected range
KGOSurgeon'S GlovesClass I · General, Plastic Surgery2559 all time4429Class I recallWithin expected range
KGXTape And Bandage, AdhesiveClass I · General Hospital0187 all time48250Class II recall3 months above expected
KITMedia And Components, Synthetic Cell And Tissue CultureClass I · Hematology0367 all time40Nothing changedNo monthly series
KKXDrape, Surgical, AntimicrobialClass II · General, Plastic Surgery0450 all time919Class II recallWithin expected range
KLEAgent, Tooth Bonding, ResinClass II · Dental8419 all time2013Worth knowingWithin expected range
KMFBandage, LiquidClass I · General Hospital0222 all time48Nothing changedWithin expected range
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Class II · Gastroenterology, Urology6188 all time1211,228Class II recall1 month above expected
KNTTubes, Gastrointestinal (And Accessories)Class II · Gastroenterology, Urology1650 all time2681,011Class II recall1 month above expected
KNWInstrument, BiopsyClass II · Gastroenterology, Urology5361 all time1061,629Class I recall3 months above expected
KNXCollector, Urine, (And Accessories) For Indwelling CatheterClass II · Gastroenterology, Urology0206 all time19119Nothing changedWithin expected range
KODCatheter, UrologicalClass II · Gastroenterology, Urology1238 all time107668Nothing changed1 month above expected
KPRSystem, X-Ray, StationaryClass II · Radiology6356 all time16832Class II recall1 month above expected
KPSSystem, Tomography, Computed, EmissionClass II · Radiology9471 all time4437Class II recall1 month above expected
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentClass II · Orthopedic10404 all time89285Serious1 month above expected
KWPAppliance, Fixation, Spinal InterlaminalClass II · Orthopedic0430 all time68309Nothing changed1 month above expected
KWQAppliance, Fixation, Spinal Intervertebral BodyClass II · Orthopedic11667 all time214177Class II recall1 month above expected
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedClass II · Orthopedic4191 all time1521,501Class II recall1 month above expected
LCPAssay, Glycosylated HemoglobinClass II · Hematology0249 all time10347Class II recallWithin expected range
LCXKit, Test, Pregnancy, Hcg, Over The CounterClass II · Clinical Chemistry1226 all time250Class II recallWithin expected range
LHISet, I.V. Fluid TransferClass II · General Hospital5206 all time611,096Worth knowing1 month above expected
LITCatheter, Angioplasty, Peripheral, TransluminalClass II · Cardiovascular3403 all time321,405Class II recallWithin expected range
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysClass II · General Hospital3302 all time3322,431Class II recallWithin expected range
LJTPort & Catheter, Implanted, Subcutaneous, IntravascularClass II · General Hospital2288 all time1413,166Class I recall3 months above expected
LLZSystem, Image Processing, RadiologicalClass II · Radiology522,281 all time552179Class II recall2 months above expected
LNHSystem, Nuclear Magnetic Resonance ImagingClass II · Radiology221,099 all time699356Class II recall1 month above expected
LONSystem, Test, Automated, Antimicrobial Susceptibility, Short IncubationClass II · Microbiology3289 all time237671Class II recall1 month above expected
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedClass II · Orthopedic9562 all time2973,872Class II recall2 months above expected
LPLLenses, Soft Contact, Daily WearClass II · Ophthalmic12486 all time70132Class II recallWithin expected range
LRKDevice, Anti-SnoringClass II · Dental18213 all time10643Class II recall2 months above expected
LYCBone Grafting Material, SyntheticClass II · Dental5231 all time141Worth knowingWithin expected range
LYYLatex Patient Examination GloveClass I · General Hospital01,954 all time61Nothing changedWithin expected range
LYZVinyl Patient Examination GloveClass I · General Hospital3799 all time70Worth knowingWithin expected range
LZAPolymer Patient Examination GloveClass I · General Hospital151,175 all time756Worth knowingWithin expected range
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedClass II · Orthopedic7532 all time1771,888Class II recall1 month above expected
MAIFastener, Fixation, Biodegradable, Soft TissueClass II · Orthopedic6220 all time961,639Class II recall2 months above expected
MAXIntervertebral Fusion Device With Bone Graft, LumbarClass II · Orthopedic22894 all time115465Class II recallWithin expected range
MBIFastener, Fixation, Nondegradable, Soft TissueClass II · Orthopedic28597 all time1132,668Class II recallWithin expected range
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Class II · Cardiovascular13426 all time2822,949Class II recall2 months above expected
MKJAutomated External Defibrillators (Non-Wearable)Class III · Cardiovascular0228 all time3348,580Class II recallWithin expected range
MNHOrthosis, Spondylolisthesis Spinal FixationClass II · Orthopedic0309 all time1549Nothing changedWithin expected range
MNIOrthosis, Spinal Pedicle FixationClass II · Orthopedic0303 all time21336Class II recall1 month above expected
MOSCoil, Magnetic Resonance, SpecialtyClass II · Radiology9489 all time381Nothing changedWithin expected range
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Class II · Radiology3423 all time19555Class II recall1 month above expected
MQLMedia, ReproductiveClass II · Obstetrics/Gynecology5259 all time152Nothing changedWithin expected range
MQPSpinal Vertebral Body Replacement DeviceClass II · Orthopedic2278 all time46108Serious2 months above expected
MQVFiller, Bone Void, Calcium CompoundClass II · Orthopedic7492 all time12041Class II recallWithin expected range
MUHSystem, X-Ray, Extraoral Source, DigitalClass II · Dental4206 all time90Worth knowingWithin expected range
MUJSystem, Planning, Radiation Therapy TreatmentClass II · Radiology13257 all time26712Class II recallWithin expected range
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Class II · Cardiovascular4306 all time77199Class II recall1 month above expected
NBWSystem, Test, Blood Glucose, Over The CounterClass II · Clinical Chemistry2509 all time1373,029Class I recallWithin expected range
NHAAbutment, Implant, Dental, EndosseousClass II · Dental37712 all time224863Class II recall3 months above expected
NKBThoracolumbosacral Pedicle Screw SystemClass II · Orthopedic31905 all time181816Class II recallWithin expected range
NUCLubricant, PersonalClass II · Obstetrics/Gynecology13246 all time77Worth knowingWithin expected range
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterClass II · Neurology11229 all timeNone5Worth knowingWithin expected range
ODPIntervertebral Fusion Device With Bone Graft, CervicalClass II · Orthopedic24352 all time1138Class III recallWithin expected range
OLOOrthopedic Stereotaxic InstrumentClass II · Neurology51437 all time1121,908Class II recall1 month above expected
OMPNegative Pressure Wound Therapy Powered Suction PumpClass II · General, Plastic Surgery9214 all time4772Worth knowing1 month above expected
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarClass II · Orthopedic7202 all time3636Class II recallWithin expected range
OWBInterventional Fluoroscopic X-Ray SystemClass II · Radiology17321 all time6208,971Class II recall4 months above expected
PHXShoulder Prosthesis, Reverse ConfigurationClass II · Orthopedic20205 all time671,992Class II recall2 months above expected
QASRadiological Computer-Assisted Triage And Notification SoftwareClass II · Radiology1686 all timeNone0Worth knowingNo monthly series
QIHAutomated Radiological Image Processing SoftwareClass II · Radiology93314 all time264Class II recallWithin 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.