Reported Reactions

Adverse event reports that FDA received

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Device types, part 1 of 4

Aberrometer, ophthalmic to Drape, surgical, antimicrobial. 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
Aberrometer, ophthalmicNCFOphthalmic1
Absorbable coronary drug-eluting stentPNYUnknown2
Abutment, implant, dental, endosseousNHADental7
Accelerator, linear, medicalIYERadiology3
Accessories, arthroscopicNBHOrthopedic3
Accessories, blood circuit, hemodialysisKOCGastroenterology, Urology1
Accessories, catheterKGZGeneral, Plastic Surgery1
Accessories, catheter, g-uKNYGastroenterology, Urology0
Accessories, cleaning brushes, for endoscopeMNLGastroenterology, Urology1
Accessories, cleaning, for endoscopeFEBGastroenterology, Urology4
Accessories, implant, dental, endosseousNDPDental7
Accessories, photographic, for endoscope (exclude light sources)FEMGastroenterology, Urology0
Accessories, pump, infusionMRZGeneral Hospital0
Accessories, soft lens productsLPNOphthalmic8
Accessories, solution, ultrasonic cleaners for lensesLYLOphthalmic1
Acid, hyaluronic, intraarticularMOZUnknown9
Activated whole blood clotting timeJBPHematology0
Active implantable bone conduction hearing systemPFOEar, Nose, Throat3
Adaptor, hygieneILSPhysical Medicine2
Adaptor, stopcock, manifold, fitting, cardiopulmonary bypassDTLCardiovascular3
Adhesive, denture, carboxymethylcellulose sodium (32%) and ethylene-oxide homopolymerKOLDental3
Adhesive, denture, polyvinyl methylether maleic acid calcium-sodium double saltKOODental0
Agent, absorbable hemostatic, collagen basedLMFGeneral, Plastic Surgery4
Agent, absorbable hemostatic, non-collagen basedLMGGeneral, Plastic Surgery2
Agent, bulking, injectable for gastro-urology useLNMUnknown3
Agent, injectable, embolicMFEUnknown3
Agent, occluding, vascular, permanentPJQUnknown1
Agent, tooth bonding, resinKLEDental1
Agents, embolic, for treatment of uterine fibroidsNAJCardiovascular1
Aid, surgical, viscoelasticLZPOphthalmic5
Aid, transferIKXPhysical Medicine1
Airway, nasopharyngealBTQAnesthesiology0
Airway, oropharyngeal, anesthesiologyCAEAnesthesiology1
Alarm, conditioned response enuresisKPNGastroenterology, Urology2
Aligner, sequentialNXCDental8
Alkaline picrate, colorimetry, creatinineCGXClinical Chemistry0
Alternate controller enabled insulin infusion pumpQFGClinical Chemistry21
Analyzer, chemistry (photometric, discrete), for clinical useJJEClinical Chemistry115
Analyzer, chemistry (sequential multiple, continuous flow) clinical useJJCClinical Chemistry0
Analyzer, gas, carbon-dioxide, gaseous-phaseCCKAnesthesiology5
Analyzer, pacemaker generator functionDTCCardiovascular2
Anesthesia conduction kitCAZAnesthesiology4
Angiography/angioplasty kitOEQCardiovascular0
Antigens, all groups, streptococcus spp.GTYMicrobiology0
Aortic valve, prosthesis, percutaneously deliveredNPTUnknown55
Apparatus, autotransfusionCACAnesthesiology2
Apparatus, exhaust, surgicalFYDGeneral, Plastic Surgery1
Apparatus, nitric oxide deliveryMRNAnesthesiology3
Apparatus, suction, operating-room, wall vacuum poweredGCXGeneral Hospital1
Apparatus, suction, patient careDWMCardiovascular1
Apparatus, suction, single patient use, portable, nonpoweredGCYGeneral, Plastic Surgery4
Apparatus, suction, ward use, portable, ac-poweredJCXGeneral, Plastic Surgery2
Apparatus, traction, non-poweredHSTOrthopedic0
Appliance, fixation, nail/blade/plate combination, multiple componentKTTOrthopedic7
Appliance, fixation, nail/blade/plate combination, multiple component, metal compositeLXTOrthopedic0
Appliance, fixation, nail/blade/plate combination, single componentKTWOrthopedic0
Appliance, fixation, spinal interlaminalKWPOrthopedic5
Appliance, fixation, spinal intervertebral bodyKWQOrthopedic7
Applicator, absorbent tipped, non-sterileKXFGeneral Hospital0
Applicator, absorbent tipped, sterileKXGGeneral Hospital1
Applier, hemostatic clipHBTGeneral, Plastic Surgery0
Applier, staple, surgical,GEFGeneral, Plastic Surgery1
Applier, surgical, clipGDOGeneral, Plastic Surgery15
Arterial blood sampling kitCBTAnesthesiology0
ArthroscopeHRXOrthopedic24
Artificial heartLOZUnknown5
Assay, enzyme linked immunosorbent, hepatitis c virusMZOMicrobiology2
Assay, glycosylated hemoglobinLCPHematology6
Automated external defibrillators (non-wearable)MKJCardiovascular100
Automated insulin dosing , threshold suspendOZOUnknown34
Automated insulin dosing device system, single hormonal controlOZPUnknown66
Automated urinalysis systemKQOClinical Chemistry1
AwlHWJOrthopedic0
Azo dye, calciumCJYClinical Chemistry0
Bag, urinary, ileostomyEXHGastroenterology, Urology0
Bag, urine collection, leg, for external use, sterileFAQGastroenterology, Urology0
Balloon aortic valvuloplastyOZTCardiovascular0
Bariatric bedOSIGeneral Hospital1
Barrier, absorbable, adhesionMCNUnknown4
Bath, hydro-massageILJPhysical Medicine2
Battery, replacement, rechargeableMOQGeneral, Plastic Surgery3
Bed, ac-powered adjustable hospitalFNLGeneral Hospital74
Bed, air fluidizedINXPhysical Medicine2
Bed, flotation therapy, poweredIOQPhysical Medicine0
Bed, manualFNJGeneral Hospital0
Bed, patient rotation, poweredIKZPhysical Medicine2
Bed, pediatric open hospitalFMSGeneral Hospital1
Bed, therapeutic, ac-powered, adjustable home-useLLIGeneral Hospital0
BenderHXWOrthopedic0
Biliary catheter for stone removal that may also allow for irrigation and contrast injectionGCAGastroenterology, Urology1
Biliary stent system for benign stricturesPNBGastroenterology, Urology0
Biopsy needleFCGGastroenterology, Urology7
Bit, drillHTWOrthopedic20
Bit, surgicalGFGGeneral, Plastic Surgery0
Blade, saw, general & plastic surgery, surgicalGFAGeneral, Plastic Surgery2
Blade, scalpelGESGeneral, Plastic Surgery0
Blood establishment computer software and accessoriesMMHHematology1
Blood grouping reagentQHRHematology0
Blood pressure cuffDXQCardiovascular0
Blood pump for ecmo, long-term (> 6 hours) useQNRCardiovascular0
Blood/plasma collection device for dna testingPJEClinical Chemistry2
Bone cementLODOrthopedic13
Bone cement, antibioticMBBOrthopedic3
Bone cement, posterior screw augmentationPMLOrthopedic0
Bone grafting material, syntheticLYCDental0
Bone millLYSOrthopedic4
Bottle, collection, vacuumKDQGeneral Hospital0
BroachHTQOrthopedic10
Bronchial thermoplasty systemOOYUnknown1
Bronchoscope (flexible or rigid)EOQEar, Nose, Throat14
Bronchoscope accessoryKTIEar, Nose, Throat1
Bur, dentalEJLDental0
Bur, ear, nose and throatEQJEar, Nose, Throat5
Bur, surgical, general & plastic surgeryGFFGeneral, Plastic Surgery1
Burr, orthopedicHTTOrthopedic0
Cabinet, table and tray, anesthesiaBRYAnesthesiology22
Cable, electrodeIKDPhysical Medicine0
Cable, transducer and electrode, patient, (including connector)DSACardiovascular1
Calculator, drug doseNDCAnesthesiology2
Calculator/data processing module, for clinical useJQPClinical Chemistry1
Calibrator, multi-analyte mixtureJIXClinical Chemistry1
Calibrator, secondaryJITClinical Chemistry1
Camera, scintillation (gamma)IYXRadiology0
Camera, surgical and accessoriesKQMGeneral, Plastic Surgery1
CaneIPSPhysical Medicine1
Cannula, catheterDQRCardiovascular0
Cannula, manipulator/injector, uterineLKFObstetrics/Gynecology3
Cannula, nasal, oxygenCATAnesthesiology2
Cannula, ophthalmicHMXOphthalmic1
Cannula, surgical, general & plastic surgeryGEAGeneral, Plastic Surgery0
Cannula, trocar, ophthalmicNGYOphthalmic1
Carboxymethylcellulose sodium or polyvinyl methylether maleic acid calcium-sodiumKOTDental0
Cardiac ablation percutaneous catheterLPBUnknown14
Cardiac catheterization kitOESCardiovascular0
Cardiovascular procedure kitOEZCardiovascular3
Catheter and tip, suctionJOLGeneral Hospital5
Catheter care trayOHRGastroenterology, Urology0
Catheter for crossing total occlusionsPDUCardiovascular3
Catheter, angioplasty, peripheral, transluminalLITCardiovascular43
Catheter, balloon typeGBAGeneral, Plastic Surgery0
Catheter, balloon, transcervicalMKNUnknown1
Catheter, cannula and tubing, vascular, cardiopulmonary bypassDWFCardiovascular3
Catheter, cholangiographyGBZGeneral, Plastic Surgery0
Catheter, conduction, anestheticBSOAnesthesiology2
Catheter, continuous flushKRACardiovascular13
Catheter, coronary, atherectomyMCXUnknown10
Catheter, coudeEZCGastroenterology, Urology9
Catheter, electrode recording, or probe, electrode recordingDRFCardiovascular12
Catheter, embolectomyDXECardiovascular8
Catheter, flow directedDYGCardiovascular3
Catheter, hemodialysis, implantedMSDGastroenterology, Urology8
Catheter, hemodialysis, non-implantedMPBGastroenterology, Urology2
Catheter, hemodialysis, triple lumen, non-implantedNIEGastroenterology, Urology0
Catheter, intracardiac mapping, high-density arrayMTDCardiovascular3
Catheter, intravascular occluding, temporaryMJNCardiovascular2
Catheter, intravascular, diagnosticDQOCardiovascular12
Catheter, intravascular, therapeutic, long-term greater than 30 daysLJSGeneral Hospital29
Catheter, intravascular, therapeutic, short-term less than 30 daysFOZGeneral Hospital23
Catheter, irrigationGBXGeneral, Plastic Surgery5
Catheter, nephrostomyLJEUnknown0
Catheter, nephrostomy, general & plastic surgeryGBOGeneral, Plastic Surgery2
Catheter, oximeter, fiber-opticDQECardiovascular0
Catheter, percutaneousDQYCardiovascular57
Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoringNWXUnknown5
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillationOAEUnknown16
Catheter, percutaneous, cardiac ablation, for treatment of atrial flutterOADUnknown11
Catheter, percutaneous, cutting/scoringPNOCardiovascular0
Catheter, percutaneous, neurovasculatureQJPCardiovascular2
Catheter, peripheral, atherectomyMCWCardiovascular8
Catheter, peritoneal, long-term indwellingFJSGastroenterology, Urology4
Catheter, recording, electrode, reprocessedNLHCardiovascular0
Catheter, retention type, balloonEZLGastroenterology, Urology10
Catheter, septostomyDXFCardiovascular5
Catheter, steerableDRACardiovascular12
Catheter, straightEZDGastroenterology, Urology7
Catheter, subclavianLFJGastroenterology, Urology1
Catheter, thrombus retrieverNRYCardiovascular9
Catheter, ultrasound, intravascularOBJCardiovascular7
Catheter, umbilical arteryFOSGeneral Hospital1
Catheter, ureteral, gastro-urologyEYBGastroenterology, Urology0
Catheter, urethralGBMGastroenterology, Urology2
Catheter, urologicalKODGastroenterology, Urology16
Catheter, urological (antimicrobial) and accessoriesMJCGastroenterology, Urology9
Catheters, suction, tracheobronchialBSYAnesthesiology2
Catheters, transluminal coronary angioplasty, percutaneousLOXCardiovascular41
Cement, bone, vertebroplastyNDNOrthopedic7
Cement, dentalEMADental2
Centrifuges (micro, ultra, refrigerated) for clinical useJQCClinical Chemistry0
Cerclage, fixationJDQOrthopedic2
Chair, adjustable, mechanicalINNPhysical Medicine0
Chair, examination and treatmentFRKGeneral Hospital2
Chair, positioning, electricINOPhysical Medicine0
Chair, with castersINMPhysical Medicine1
Charger, pacemakerKRFCardiovascular0
Chisel, surgical, manualFZOGeneral, Plastic Surgery0
Choledochoscope and accessories, flexible/rigidFBNGastroenterology, Urology3
Circuit, breathing (w connector, adaptor, y piece)CAIAnesthesiology2
ClampHXDGeneral, Plastic Surgery2
Clamp, circumcisionHFXObstetrics/Gynecology1
Clamp, rubber damEEFDental0
Clamp, surgical, general & plastic surgeryGDJGeneral, Plastic Surgery0
Clamp, vascularDXCCardiovascular5
Cleanser, denture, over the counterEFTDental0
Clip, hemostaticMCHGeneral, Plastic Surgery0
Clip, implantableFZPGeneral, Plastic Surgery33
Closed antineoplastic and hazardous drug reconstitution and transfer systemONBGeneral Hospital1
Coagulator-cutter, endoscopic, unipolar (and accessories)KNFObstetrics/Gynecology0
Collector, ostomyEXBGastroenterology, Urology0
Collector, urine, (and accessories) for indwelling catheterKNXGastroenterology, Urology4
Collector, urine, powered, non indwelling catheterNZUGastroenterology, Urology4
Colonoscope and accessories, flexible/rigidFDFGastroenterology, Urology10
Colorimeter, photometer, spectrophotometer for clinical useJJQClinical Chemistry0
Compressor, air, portableBTIAnesthesiology5
Compressor, cardiac, externalDRMCardiovascular10
Computer, blood-pressureDSKCardiovascular0
Computer, diagnostic, pre-programmed, single-functionDXGCardiovascular0
Computer, diagnostic, programmableDQKCardiovascular3
Condenser, heat and moisture (artificial nose)BYDAnesthesiology0
CondomHISObstetrics/Gynecology0
Condylar plate fixation implantJDPOrthopedic0
Confocal optical imagingOWNGastroenterology, Urology1
Connector, airway (extension)BZAAnesthesiology0
Console, heart-lung machine, cardiopulmonary bypassDTQCardiovascular12
Container, empty, for collection & processing of blood & blood componentsKSRHematology0
Container, i.v.KPEGeneral Hospital5
Container, sharpsMMKGeneral Hospital0
Container, specimen, sterileFMHPathology0
Continuous glucose monitor retrospective data analysis softwarePHVClinical Chemistry3
Continuous glucose monitor, implanted, adjunctive useQCDUnknown1
Continuous measurement thermometerFLLGeneral Hospital2
Continuous, ventilator, home useNOUAnesthesiology4
Control, pump speed, cardiopulmonary bypassDWACardiovascular5
Controller, foot, handpiece and cordEBWDental0
Controller, temperature, cardiopulmonary bypassDWCCardiovascular6
Coronary covered stentNIVUnknown0
Coronary drug-eluting stentNIQUnknown56
Coronavirus antigen detection test system.QKPUnknown18
Counter, differential cellGKZHematology24
Counter, sponge, surgicalLWHGeneral Hospital0
Covid-19 multi-analyte antigen deviceQMNUnknown3
Covid-19 multi-analyte respiratory panel nucleic acid devicesQLTUnknown2
CrutchIPRPhysical Medicine0
Cuff, tracheal tube, inflatableBSKAnesthesiology1
Culture media, antimicrobial susceptibility test, excluding mueller hinton agarJSOMicrobiology0
Culture media, enrichedKZIMicrobiology3
Culture media, non-propagating transportJSMMicrobiology0
Culture media, non-selective and non-differentialJSGMicrobiology1
Culture media, selective and non-differentialJSJMicrobiology1
Cup, menstrualHHEObstetrics/Gynecology1
Cutaneous tissue adhesive with meshOMDGeneral, Plastic Surgery5
Cutter, surgicalFZTGeneral, Plastic Surgery1
Cutter, wireHXZOrthopedic0
Cystoscope and accessories, flexible/rigidFAJGastroenterology, Urology4
Dc-defibrillator, low-energy, (including paddles)LDDCardiovascular16
Decontamination systems for n95 respiratorsQKYUnknown0
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)NIKUnknown104
Defibrillator, implantable, dual-chamberMRMUnknown5
Dermal cooling pack/vacuum/massagerOOKGeneral, Plastic Surgery4
DermatomeGFDGeneral, Plastic Surgery8
Detector and alarm, arrhythmiaDSICardiovascular11
Device, anastomotic, microvascularMVRGeneral, Plastic Surgery2
Device, angioplasty, laser, coronaryLPCUnknown0
Device, anti-snoringLRKDental4
Device, electroconvulsive therapyGXCNeurology0
Device, endoscopic suturingMFJGastroenterology, Urology0
Device, fixation, tracheal tubeCBHAnesthesiology0
Device, hemostasis, vascularMGBUnknown52
Device, impotence, mechanical/hydraulicFHWGastroenterology, Urology17
Device, incontinence, mechanical/hydraulicEZYGastroenterology, Urology4
Device, incontinence, urosheath type, non-sterileNNXGastroenterology, Urology1
Device, intravascular catheter securementKMKGeneral Hospital0
Device, irrigation, ocular surgeryKYGOphthalmic2
Device, medical examination, ac poweredKZFGeneral Hospital1
Device, microtiter diluting/dispensingJTCMicrobiology2
Device, monitoring, intracranial pressureGWMNeurology10
Device, neurovascular embolizationHCGNeurology22
Device, percutaneous retrievalMMXCardiovascular0
Device, removal, pacemaker electrode, percutaneousMFAUnknown3
Device, thermal ablation, endometrialMNBUnknown7
Device, urine flow rate measuring, non-electrical, disposableFFGGastroenterology, Urology0
Device, vascular, for promoting embolizationKRDCardiovascular15
Device, warming. blood and plasmaKZLHematology0
Dialysate concentrate for hemodialysis (liquid or powder)KPOGastroenterology, Urology3
Dialyzer, capillary, hollow fiberFJIGastroenterology, Urology7
Dialyzer, high permeability with or without sealed dialysate systemKDIGastroenterology, Urology40
Diazo colorimetry, bilirubinCIGClinical Chemistry0
Digital breast tomosynthesisOTEUnknown3
Dilator, catheter, ureteralEZNGastroenterology, Urology2
Dilator, esophagealKNQGastroenterology, Urology8
Dilator, vessel, for percutaneous catheterizationDRECardiovascular2
Disinfectant, medical devicesLRJGeneral Hospital2
Disinfector, medical devicesMECGeneral Hospital1
Dislodger, stone, basket, ureteral, metalFFLGastroenterology, Urology7
Dislodger, stone, biliaryLQRGastroenterology, Urology1
Dislodger, stone, flexibleFGOGastroenterology, Urology0
Dispenser, cementKIHOrthopedic0
Display, cathode-ray tube, medicalDXJCardiovascular0
Dissector, surgical, general & plastic surgeryGDIGeneral, Plastic Surgery0
Dorsal root ganglion stimulator for pain reliefPMPUnknown9
Drape, surgical, antimicrobialKKXGeneral, Plastic Surgery0