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Adverse event reports that FDA received

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Device types, part 2 of 4

Drape, surgical, exempt to Microspheres radionuclide. Each name goes to the page of the device type, with FDA's statement on the data and the brand names of the type.

300 device types in order of name, with the product code, the panel and the number of brand pages
Device typeProduct codePanelBrand pages
Drape, surgical, exemptPUIGeneral, Plastic Surgery0
Dressing, wound, drugFROUnknown0
Dressing, wound, hydrophilicNACGeneral, Plastic Surgery2
Dressing, wound, occlusiveNADGeneral, Plastic Surgery3
Drill, bone, poweredDZIDental0
Drill, dental, intraoralDZADental0
Drill, surgical, ent (electric or pneumatic) including handpieceERLEar, Nose, Throat40
Drills, burrs, trephines & accessories (compound, powered)HBFNeurology4
Drills, burrs, trephines & accessories (simple, powered)HBENeurology24
Driver, prosthesisHWROrthopedic14
Driver, wire, and bone drill, manualDZJDental3
Drug eluting permanent left ventricular (lv) pacemaker electrodeOJXUnknown34
Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodesNVNUnknown54
Drug-coated peripheral transluminal angioplasty catheterPRCUnknown1
Drug-eluting percutaneous transluminal coronary angioplasty catheterOOBUnknown1
Drug-eluting peripheral transluminal angioplasty catheterONUUnknown7
Duodenoscope and accessories, flexible/rigidFDTGastroenterology, Urology6
Dura substituteGXQNeurology0
Ear, nose, and throat stereotaxic instrumentPGWNeurology2
ElectrocardiographDPSCardiovascular0
Electrocautery, gynecologic (and accessories)HGIObstetrics/Gynecology2
Electrode measurement, blood-gases (pco2, po2) and blood phCHLClinical Chemistry4
Electrode, cutaneousGXYNeurology0
Electrode, electrocardiographDRXCardiovascular3
Electrode, electrocardiograph, multi-functionMLNCardiovascular1
Electrode, electrosurgicalJOSGeneral, Plastic Surgery0
Electrode, electrosurgical, active, urologicalFASGastroenterology, Urology2
Electrode, ion specific, potassiumCEMClinical Chemistry0
Electrode, ion specific, sodiumJGSClinical Chemistry2
Electrode, needleGXZNeurology0
Electrode, pacemaker, temporaryLDFCardiovascular2
Electrode, ph, stomachFFTGastroenterology, Urology3
Electrosurgical, cutting & coagulation & accessoriesGEIGeneral, Plastic Surgery125
Electrosurgical, cutting & coagulation accessories, laparoscopic & endoscopic, reprocessedNUJGeneral, Plastic Surgery0
Elevator, surgical, dentalEMJDental1
Endoscope channel accessoryODCGastroenterology, Urology1
Endoscope, ac-powered and accessoriesGCPGastroenterology, Urology1
Endoscope, accessories, image post-processing for color enhancementPEAGastroenterology, Urology0
Endoscope, accessories, narrow band spectrumNWBGastroenterology, Urology4
Endoscope, rigidGCMGastroenterology, Urology2
Endoscopic access overtube, gastroenterology-urologyFEDGastroenterology, Urology2
Endoscopic cytology brushFDXGastroenterology, Urology1
Endoscopic grasping/cutting instrument, non-poweredOCZGastroenterology, Urology2
Endoscopic grasping/cutting instrument, non-powered, exemptPTSGastroenterology, Urology0
Endoscopic guidewire, gastroenterology-urologyOCYGastroenterology, Urology2
Endoscopic injection needle, gastroenterology-urologyFBKGastroenterology, Urology1
Endoscopic suture/plication system, gastroesophageal reflux disease (gerd)ODEGastroenterology, Urology0
Endoscopic tissue approximation deviceOCWGastroenterology, Urology3
Endoscopic ultrasound system, gastroenterology-urologyODGGastroenterology, Urology3
Endoscopic video imaging system/component, gastroenterology-urologyFETGastroenterology, Urology19
Endovascular suturing systemOTDCardiovascular1
Enteral specific transition connectorsPIOGastroenterology, Urology0
Enteroscope and accessoriesFDAGastroenterology, Urology1
Enzymatic method, creatinineJFYClinical Chemistry1
Enzyme immunoassay, digoxinKXTClinical Toxicology0
Enzyme immunoassay, diphenylhydantoinDIPClinical Toxicology1
Enzyme immunoassay, phenobarbitalDLZClinical Toxicology1
Enzyme immunoassay, tracrolimusMLMClinical Chemistry0
Enzyme immunoassay, valproic acidLEGClinical Toxicology1
Enzyme linked immunoabsorbent assay, cytomegalovirusLFZMicrobiology0
Enzyme linked immunoabsorbent assay, rubellaLFXMicrobiology1
Enzyme linked immunoabsorbent assay, toxoplasma gondiiLGDMicrobiology1
Enzyme linked immunoabsorption assay, treponema pallidumLIPMicrobiology1
Enzyme linked immunosorbent assay, herpes simplex virus, hsv-2MYFMicrobiology0
Epidural anesthesia kitOGEAnesthesiology2
Equipment, laboratory, general purpose, labeled or promoted for a specific medical useLXGClinical Chemistry0
Excimer laser systemLZSUnknown10
Expander, surgical, skin graftFZWGeneral, Plastic Surgery3
Extended depth of focus intraocular lensPOEOphthalmic8
External mandibular fixator and/or distractorMQNDental2
Extracorporeal system for long-term respiratory / cardiopulmonary failureQJZCardiovascular1
ExtractorHWBOrthopedic6
Extractor, vacuum, fetalHDBObstetrics/Gynecology0
Fall prevention alarm/sensor combination attached or unattachedPJOGeneral Hospital1
Fastener, fixation, biodegradable, soft tissueMAIOrthopedic18
Fastener, fixation, nondegradable, soft tissueMBIOrthopedic30
Fibrin sealant preparation deviceMZMGeneral Hospital1
File, pulp canal, endodonticEKSDental5
Filler, bone void, calcium compoundMQVOrthopedic1
Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinductionNEKUnknown2
Filter, bacterial, breathing-circuitCAHAnesthesiology0
Filter, infusion lineFPBGeneral Hospital1
Filter, intravascular, cardiovascularDTKCardiovascular47
Floss, dentalJESDental0
Flow cytometric reagents and accessories.OYEHematology1
Fluid jet removal systemPZPGeneral, Plastic Surgery2
Fluorometer, for clinical useKHOClinical Chemistry4
Folders and injectors, intraocular lens (iol)MSSOphthalmic4
ForcepsHTDGeneral, Plastic Surgery2
Forceps, biopsy, electricKGEGastroenterology, Urology0
Forceps, biopsy, non-electricFCLGastroenterology, Urology5
Forceps, general & plastic surgeryGENGeneral, Plastic Surgery0
Forceps, ophthalmicHNROphthalmic1
Full field digital, system, x-ray, mammographicMUERadiology2
Full-montage standard electroencephalographGWQNeurology0
Gas control unit, cardiopulmonary bypassDTXCardiovascular1
Gas-machine, anesthesiaBSZAnesthesiology26
Gases used within eye to place pressure on detached retinaLPOOphthalmic1
Gastrointestinal tubes with enteral specific connectorsPIFGastroenterology, Urology0
Gastroscope and accessories, flexible/rigidFDSGastroenterology, Urology6
Gauge, depthHTJOrthopedic3
Gauze/sponge, internal, x-ray detectableGDYGeneral, Plastic Surgery2
General purpose reagentPPMPathology1
General surgery trayLROGeneral, Plastic Surgery9
Generator, lesion, radiofrequencyGXDNeurology2
Generator, oxygen, portableCAWAnesthesiology14
Generator, pulsatile flow, cardiopulmonary bypassJORCardiovascular0
Glucose dehydrogenase, glucoseLFRClinical Chemistry16
Glucose oxidase, glucoseCGAClinical Chemistry5
Glue, surgical, arteriesMUQUnknown1
Gown, surgicalFYAGeneral, Plastic Surgery0
Graft, vascular, synthetic/biologic compositeMALCardiovascular1
Gram negative identification panelLQMMicrobiology0
Gram-positive bacteria and their resistance markersPAMMicrobiology1
Growing rod system- magnetic actuationPGNOrthopedic1
Guide, surgical, instrumentFZXGeneral, Plastic Surgery2
Guide, wire, catheter, neurovasculatureMOFCardiovascular0
Gynecological laparoscopic kitOHDObstetrics/Gynecology1
Hammer, surgicalFZYGeneral, Plastic Surgery0
Handpiece, air-powered, dentalEFBDental2
Handpiece, contra- and right-angle attachment, dentalEGSDental3
Handpiece, direct drive, ac-poweredEKXDental1
Handpiece, rotary bone cuttingKMWDental0
Hearing aid, air-conduction with wireless technology, prescriptionOSMEar, Nose, Throat1
Hearing aid, air-conduction, prescriptionESDEar, Nose, Throat0
Hearing aid, bone conductionLXBEar, Nose, Throat6
Hearing aid, bone conduction, implantedMAHEar, Nose, Throat8
Heart-valve, allograftMIEUnknown1
Heart-valve, mechanicalLWQUnknown9
Heart-valve, non-allograft tissueLWRUnknown21
Heat-exchanger, cardiopulmonary bypassDTRCardiovascular0
Heater, breathing system w/wo controller (not humidifier or nebulizerBZEAnesthesiology5
Hemodialyzer, re-use, high fluxMSFGastroenterology, Urology2
Hemostatic device for endoscopic gastrointestinal useQAUGeneral, Plastic Surgery1
Hemostatic metal clip for the gi tractPKLGastroenterology, Urology7
Heparin, vascular access flushNZWGeneral Hospital1
Hepatitis a test (antibody and igm antibody)LOLMicrobiology2
Hexokinase, glucoseCFRClinical Chemistry16
Hip prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncementedOQGOrthopedic1
Holder, head, neurosurgical (skull clamp)HBLNeurology8
Holder, needle, gastroenterologicFHQGastroenterology, Urology2
Holder, ureteral catheterEYJGastroenterology, Urology2
Humidifier nebulizer kitOGGAnesthesiology0
Humidifier, non-direct patient interface (home-use)KFZAnesthesiology1
Humidifier, respiratory gas, (direct patient interface)BTTAnesthesiology17
Hybrid stent graft, thoracic aortic lesion treatmentQSKUnknown0
Hydrogel spacerOVBRadiology3
Hysteroscope (and accessories)HIHObstetrics/Gynecology10
I.v. start kitLRSGeneral Hospital0
Iliac covered stent, arterialPRLUnknown3
Image, illumination, fiberoptic, for endoscopeFFSGastroenterology, Urology0
Image-intensified fluoroscopic x-ray system, mobileOXORadiology4
Immunoassay method, troponin subunitMMIClinical Chemistry20
ImpactorHWAOrthopedic17
Implant, anti-gastroesophageal refluxLEIUnknown6
Implant, cochlearMCMUnknown35
Implant, corneal, refractiveLQEUnknown1
Implant, dermal, for aesthetic useLMHUnknown35
Implant, endosseous, orthodonticOATDental1
Implant, endosseous, root-formDZEDental1,342
Implant, eye valveKYFOphthalmic7
Implant, fixation device, spinalJDNOrthopedic0
Implant, hearing, active, middle ear, partially implantedMPVUnknown1
Implant, intragastric for morbid obesityLTIUnknown18
Implantable cardioverter defibrillator (non-crt)LWSUnknown148
Implantable pacemaker pulse-generatorDXYCardiovascular32
Implantable pulse generator, pacemaker (non-crt)LWPUnknown42
Implantable transprostatic tissue retractor systemPEWGastroenterology, Urology0
Implanted brain stimulator for epilepsyPFNUnknown1
Implanted fecal incontinence deviceMIPUnknown1
Implanted subcortical electrical stimulator (motor disorders)MRUUnknown0
Incubator, neonatalFMZGeneral Hospital2
Index-generating electroencephalograph softwareOLWNeurology1
Indicator, biological sterilization processFRCGeneral Hospital2
Indicator, physical/chemical sterilization processJOJGeneral Hospital0
Infant heel warmer (chemical heat pack)MPOPhysical Medicine0
Infusion pump, drug specific, pharmacy-filledQJYGeneral Hospital1
Infusor, pressure, for i.v. bagsKZDGeneral Hospital0
Inhibitor, peridural fibrosis (adhesion barrier)MLQUnknown1
Injector and syringe, angiographicDXTCardiovascular3
Injector, contrast medium, automaticIZQCardiovascular0
Injector, fluid, non-electrically poweredKZEGeneral Hospital0
Injector, penNSCGeneral Hospital1
Instrument for treatment of hyperhidrosisOUBGeneral, Plastic Surgery1
Instrument, biopsyKNWGastroenterology, Urology14
Instrument, coagulation, automatedGKPHematology1
Instrument, compressionHWNOrthopedic1
Instrument, cutting, orthopedicHTZGeneral, Plastic Surgery0
Instrument, ent manual surgicalLRCEar, Nose, Throat0
Instrument, ligature passing and knot tyingHCFGeneral, Plastic Surgery0
Instrument, manual, surgical, general useMDMGeneral, Plastic Surgery4
Instrument, surgical, disposableKDCGeneral, Plastic Surgery2
Instrument, surgical, non-poweredHAONeurology0
Instrument, surgical, orthopedic, ac-powered motor and accessory/attachmentHWEGeneral, Plastic Surgery45
Instrument, surgical, orthopedic, dc-powered motor and accessory/attachmentKIJGeneral, Plastic Surgery5
Instrument, surgical, orthopedic, pneumatic powered & accessory/attachmentHSZGeneral, Plastic Surgery2
Instrument, ultrasonic surgicalLFLUnknown54
Instrument, vitreous aspiration and cutting, ac-poweredHQEOphthalmic6
Instruments, dental handDZNDental1
Instruments, surgical, cardiovascularDWSCardiovascular0
Insufflator, automatic carbon-dioxide for endoscopeFCXGastroenterology, Urology1
Insufflator, hysteroscopicHIGObstetrics/Gynecology1
Insufflator, laparoscopicHIFObstetrics/Gynecology3
Insulin pump secondary displayPKUClinical Chemistry4
Integrated continuous glucose monitor for non-intensive glucose monitoring, over-the-counterSAFClinical Chemistry1
Integrated continuous glucose monitoring system for non-intensive diabetes managementQDKClinical Chemistry0
Integrated continuous glucose monitoring system with sensor containing dexamethasone acetateSBAClinical Chemistry1
Integrated continuous glucose monitoring system, factory calibratedQBJClinical Chemistry19
Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systemsQLGClinical Chemistry6
Interoperable automated glycemic controllerQJIClinical Chemistry0
Interventional fluoroscopic x-ray systemOWBRadiology11
Intervertebral fusion device with bone graft, cervicalODPOrthopedic0
Intervertebral fusion device with bone graft, lumbarMAXOrthopedic10
Intervertebral fusion device with integrated fixation, cervicalOVEOrthopedic1
Intervertebral fusion device with integrated fixation, lumbarOVDOrthopedic1
Intestinal stimulatorLNQUnknown1
Intracranial aneurysm flow diverterOUTUnknown7
Intracranial coil-assist stentQCAUnknown1
Intracranial neurovascular stentNJEUnknown8
Intraocular lensHQLOphthalmic68
Intraocular pressure lowering implantOGOUnknown5
Intrasaccular flow disruption deviceOPRUnknown1
Intrauterine tamponade balloonOQYObstetrics/Gynecology3
Introducer, catheterDYBCardiovascular49
Introducer, syringe needleKZHGeneral Hospital3
Joint, knee, external braceITQPhysical Medicine1
Joint, knee, external limb componentISYPhysical Medicine0
Joint, temporomandibular, implantLZDDental2
Keratome, ac-poweredHNOOphthalmic3
Kit, dna detection, human papillomavirusMAQUnknown0
Kit, surgical instrument, disposableKDDGeneral, Plastic Surgery0
Knife, ophthalmicHNNOphthalmic7
Lamp, surgicalFTDGeneral, Plastic Surgery0
Laparoscope, general & plastic surgeryGCJGastroenterology, Urology71
Laparoscope, general & plastic surgery, reprocessedNLMGastroenterology, Urology0
Laparoscope, gynecologic (and accessories)HETObstetrics/Gynecology4
Laparoscopic accessories, gynecologicNWVObstetrics/Gynecology1
Laparoscopic contraceptive tubal occlusion deviceKNHObstetrics/Gynecology1
Laparoscopy kitFDEGastroenterology, Urology0
Laryngoscope, endoscopeGCIGastroenterology, Urology2
Laryngoscope, non-rigidCALAnesthesiology0
Laryngoscope, rigidCCWAnesthesiology8
Laser, ophthalmicHQFOphthalmic1
Latex patient examination gloveLYYGeneral Hospital2
Lavage, jetFQHGeneral Hospital5
Lead, atomic absorptionDOFClinical Toxicology0
Leadless pacemakerPNJCardiovascular8
Lectins and protectinsKSIHematology1
Lens, contact, (disposable)MVNOphthalmic0
Lens, guide, intraocularKYBOphthalmic12
Lens, intraocular, accommodativeNAAOphthalmic2
Lens, intraocular, phakicMTAUnknown3
Lens, intraocular, toric opticsMJPOphthalmic11
Lens, multifocal intraocularMFKOphthalmic11
Lenses, soft contact, daily wearLPLOphthalmic3
Lenses, soft contact, extended wearLPMOphthalmic6
Lift, patient, ac-poweredFNGGeneral Hospital1
Lift, patient, non-ac-poweredFSAGeneral Hospital18
Ligator, esophagealMNDGastroenterology, Urology5
Ligator, hemorrhoidalFHNGastroenterology, Urology0
Light adjustable lens (lal) and light delivery device (ldd)PZKOphthalmic2
Light source, endoscope, xenon arcGCTGastroenterology, Urology3
Light source, fiberoptic, routineFCWGastroenterology, Urology4
Light, surgical, accessoriesFTAGeneral, Plastic Surgery0
Light, surgical, ceiling mountedFSYGeneral, Plastic Surgery5
Light, surgical, fiberopticFSTGeneral, Plastic Surgery0
Lithotriptor, biliary mechanicalLQCGastroenterology, Urology4
Lithotriptor, electro-hydraulicFFKGastroenterology, Urology0
Lithotriptor, extracorporeal shock-wave, urologicalLNSGastroenterology, Urology0
Lithotriptor, ultrasonicFEOGastroenterology, Urology3
Locator, root apexLQYUnknown4
Manometer, spinal-fluidFMJGeneral Hospital1
Marker, radiographic, implantableNEUGeneral, Plastic Surgery1
Mask, oxygenBYGAnesthesiology0
Mask, surgicalFXXGeneral, Plastic Surgery0
Mass spectrometry, maldi tof, microorganism identification, cultured isolatesQBNMicrobiology0
Material, impressionELWDental0
Material, tooth shade, resinEBFDental2
Mattress, air flotation, alternating pressureFNMGeneral Hospital1
Mattress, flotation therapy, non-poweredIKYGeneral Hospital0
Mediastinoscope, surgicalEWYEar, Nose, Throat1
Medical device data systemOUGGeneral Hospital3
Mesh, surgicalFTMGeneral, Plastic Surgery13
Mesh, surgical, absorbable, abdominal herniaOWTGeneral, Plastic Surgery1
Mesh, surgical, absorbable, plastic and reconstructive surgeryOXFGeneral, Plastic Surgery0
Mesh, surgical, absorbable, staple line reinforcementOXCGeneral, Plastic Surgery1
Mesh, surgical, for stress urinary incontinence, maleOTMGeneral, Plastic Surgery3
Mesh, surgical, non-synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placedPAJGeneral, Plastic Surgery1
Mesh, surgical, non-synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturatorPAGGeneral, Plastic Surgery0
Mesh, surgical, polymericFTLGeneral, Plastic Surgery132
Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placedOTOGeneral, Plastic Surgery6
Mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placedOTPObstetrics/Gynecology13
Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-slingPAHGeneral, Plastic Surgery5
Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturatorOTNGeneral, Plastic Surgery30
Method, enzymatic, glucose (urinary, non-quantitative)JILClinical Chemistry1
Methyl methacrylate for cranioplastyGXPNeurology0
Microfilter, blood transfusionCAKGeneral Hospital2
Microscope, operating & accessories, ac-powered, ophthalmicHRMGeneral, Plastic Surgery1
Microscope, surgicalEPTGeneral, Plastic Surgery0
Microspheres radionuclideNAWUnknown1