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Adverse event reports that FDA received

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Device types, part 3 of 4

Midline catheter to Support, patient position. 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
Midline catheterPNDGeneral Hospital0
Mitral valve repair devicesNKMUnknown13
Mixer, breathing gases, anesthesia inhalationBZRAnesthesiology0
Mixer, cement, for clinical useJDZOrthopedic1
Modular electromechanical surgical systemSCVGeneral, Plastic Surgery2
Monitor, apnea, facility useFLSAnesthesiology0
Monitor, bed patientKMIGeneral Hospital3
Monitor, blood-gas, on-line, cardiopulmonary bypassDRYCardiovascular4
Monitor, cardiac (incl. cardiotachometer & rate alarm)DRTCardiovascular1
Monitor, physiological, patient (without arrhythmia detection or alarms)MWICardiovascular2
Monitor, physiological, patient(with arrhythmia detection or alarms)MHXCardiovascular43
Motor, drill, electricHBCNeurology28
Motor, drill, pneumaticHBBNeurology13
Motor, surgical instrument, ac-poweredGEYGeneral, Plastic Surgery11
Motor, surgical instrument, pneumatic poweredGETGeneral, Plastic Surgery1
Mouthguard, over-the-counterOBRUnknown1
Mouthguard, prescriptionMQCUnknown0
Multi-analyte test system with algorithmic analysis for detection of prostate cancerQRFUnknown1
Nad reduction/nadh oxidation, cpk or isoenzymesCGSClinical Chemistry1
Nail, fixation, boneJDSOrthopedic5
Nasopharyngoscope (flexible or rigid)EOBEar, Nose, Throat4
Nebulizer (direct patient interface)CAFAnesthesiology2
Nebulizer, medicinal, non-ventilatory (atomizer)CCQAnesthesiology1
Needle, aspiration and injection, disposableGAAGeneral, Plastic Surgery3
Needle, catheterGCBGeneral, Plastic Surgery0
Needle, conduction, anesthetic (w/wo introducer)BSPAnesthesiology0
Needle, dentalDZMDental0
Needle, fistulaFIEGastroenterology, Urology0
Needle, hypodermic, single lumenFMIGeneral Hospital33
Needle, suturing, disposableGABGeneral, Plastic Surgery0
Negative pressure wound therapy powered suction pumpOMPGeneral, Plastic Surgery11
Neurological stereotaxic instrumentHAWNeurology27
Neurosurgical paddieHBANeurology0
Normothermic machine perfusion system for the preservation of donor livers prior to transplantationQQKUnknown1
Nucleic-acid tests used for infectious disease screening of blood and plasma donationsQHOMicrobiology1
Occluder, patent ductus, arteriosusMAEUnknown2
Operating room accessories table trayFWZGeneral, Plastic Surgery1
Ophthalmic femtosecond laserOOEOphthalmic2
Orthopedic manual surgical instrumentLXHOrthopedic47
Orthopedic stereotaxic instrumentOLONeurology21
Orthopedic trayOJHGeneral, Plastic Surgery0
Orthosis, limb braceIQIPhysical Medicine0
Orthosis, spinal pedicle fixationMNIOrthopedic1
Orthosis, spondylolisthesis spinal fixationMNHOrthopedic4
OsteotomeHWMGeneral, Plastic Surgery0
Outpatient cardiac telemetryQYXCardiovascular1
Over-the-counter automated external defibrillatorNSACardiovascular1
OximeterDQACardiovascular13
Oximeter, tissue saturationMUDCardiovascular1
Oxygenator, cardiopulmonary bypassDTZCardiovascular9
Pacemaker lead adaptorDTDCardiovascular0
Pacemaker, cardiac, external transcutaneous (non-invasive)DROCardiovascular0
Pacemaker/icd/crt non-implanted componentsOSRUnknown4
Pack, hot or cold, disposableIMDPhysical Medicine5
Pack, hot or cold, reusableIMEPhysical Medicine0
Pack, hot or cold, water circulatingILOPhysical Medicine0
Pad, alcohol, device disinfectantLKBUnknown0
Pad, heating, poweredIRTPhysical Medicine8
Pancreatic stent, covered, metallic, removablePCUGastroenterology, Urology3
PasserHWQOrthopedic1
Patch, pledget and intracardiac, petp, ptfe, polypropyleneDXZCardiovascular1
Patient bed with canopy/restraintsOYSGeneral Hospital2
Patient examination gloveFMCGeneral Hospital2
Percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporationQZIUnknown8
Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis accessPQKCardiovascular1
Percutaneously delivered prostheses and tricuspid valvesNPWUnknown2
Perforator, ear-lobeJYSEar, Nose, Throat1
Peripheral mechanical thrombectomy with aspirationQEWCardiovascular1
Permanent defibrillator electrodesNVYUnknown58
Permanent pacemaker electrodeDTBCardiovascular66
Pessary, vaginalHHWObstetrics/Gynecology1
Phakic toric intraocular lensQCBOphthalmic5
Photometric method, magnesiumJGJClinical Chemistry0
Pin, fixation, smoothHTYOrthopedic1
Pin, fixation, threadedJDWOrthopedic2
Plate, boneJEYDental11
Plate, cranioplasty, preformed, alterableGWONeurology1
Plate, cranioplasty, preformed, non-alterableGXNNeurology0
Plate, fixation, boneHRSOrthopedic7
Platelet and plasma separator for bone graft handlingORGHematology0
Pliers, surgicalHTCGeneral, Plastic Surgery0
Polymer patient examination gloveLZAGeneral Hospital0
Port & catheter, implanted, subcutaneous, intravascularLJTGeneral Hospital26
Positioner, tooth, preformedKMYDental1
Posterior cervical screw systemNKGOrthopedic1
Posterior metal/polymer spinal system, fusionNQPOrthopedic0
Posterior ratcheting rod systemQGPUnknown0
Pouch, colostomyEZQGastroenterology, Urology1
Powered laser surgical instrumentGEXGeneral, Plastic Surgery41
ProbeHXBOrthopedic0
Probe, blood-flow, extravascularDPTCardiovascular0
Probe, radiofrequency lesionGXINeurology0
Probe, thermodilutionKRBCardiovascular0
Processor, cervical cytology slide, automatedMKQUnknown0
Processor, tissue, automatedIEOPathology1
Programmer, pacemakerKRGCardiovascular8
Prostate-specific antigen (psa) for management of prostate cancersLTJImmunology0
Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finishMAYOrthopedic0
Prosthesis, ankle, semi-constrained, cemented, metal/polymerHSNOrthopedic6
Prosthesis, ankle, uncemented, non-constrainedNTGUnknown2
Prosthesis, breast, inflatable, internal, salineFWMGeneral, Plastic Surgery32
Prosthesis, breast, noninflatable, internal, silicone gel-filledFTRGeneral, Plastic Surgery51
Prosthesis, elbow, constrained, cementedJDCOrthopedic1
Prosthesis, elbow, hemi-, radial, polymerKWIOrthopedic0
Prosthesis, elbow, semi-constrained, cementedJDBOrthopedic0
Prosthesis, esophagealESWGeneral, Plastic Surgery5
Prosthesis, finger, constrained, polymerKYJOrthopedic0
Prosthesis, hip, constrained, cemented or uncemented, metal/polymerKWZOrthopedic1
Prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additivePBIOrthopedic1
Prosthesis, hip, femoral component, cemented, metalJDGOrthopedic8
Prosthesis, hip, femoral, resurfacingKXAOrthopedic12
Prosthesis, hip, hemi-, acetabular, cemented, metalKWBOrthopedic4
Prosthesis, hip, hemi-, femoral, metalKWLOrthopedic0
Prosthesis, hip, hemi-, femoral, metal ballLZYOrthopedic1
Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncementedKWYOrthopedic5
Prosthesis, hip, hemi-, trunnion-bearing, femoral, metal/polyacetalJDHOrthopedic3
Prosthesis, hip, semi-constrained (metal cemented acetabular component)JDLOrthopedic3
Prosthesis, hip, semi-constrained (metal uncemented acetabular component)KWAOrthopedic146
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncementedMRAUnknown2
Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncementedLZOOrthopedic28
Prosthesis, hip, semi-constrained, metal/metal, resurfacingNXTUnknown8
Prosthesis, hip, semi-constrained, metal/polymer, cementedJDIOrthopedic58
Prosthesis, hip, semi-constrained, metal/polymer, porous uncementedLPHOrthopedic94
Prosthesis, hip, semi-constrained, metal/polymer, uncementedLWJOrthopedic2
Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphateMEHOrthopedic6
Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porousMBLOrthopedic0
Prosthesis, intervertebral discMJOUnknown4
Prosthesis, knee patellofemorotibial, partial, semi-constrained, cemented, polymer/metal/polymerNPJOrthopedic0
Prosthesis, knee, femorotibial, constrained, cemented, metal/polymerKROOrthopedic2
Prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymerHSXOrthopedic1
Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymerHRYOrthopedic6
Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearingNRAUnknown4
Prosthesis, knee, hemi-, femoralHSAOrthopedic0
Prosthesis, knee, hemi-, patellar resurfacing, uncementedHTGOrthopedic0
Prosthesis, knee, hemi-, tibial, resurfacing (uncemented)HSHOrthopedic5
Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymerMBHOrthopedic7
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additiveOIYOrthopedic0
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymerJWHOrthopedic109
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearingNJLUnknown27
Prosthesis, metatarsophalangeal joint cartilage replacement implantPNWUnknown1
Prosthesis, mitral valve, percutaneously deliveredNPUUnknown0
Prosthesis, penileFAEGastroenterology, Urology3
Prosthesis, penis, inflatableJCWGastroenterology, Urology3
Prosthesis, rib replacementMDIOrthopedic0
Prosthesis, shoulder, hemi-, humeral, metallic uncementedHSDOrthopedic19
Prosthesis, shoulder, non-constrained, metal/polymer cementedKWTOrthopedic4
Prosthesis, shoulder, semi-constrained, metal/polymer + additive, cementedPAOOrthopedic0
Prosthesis, shoulder, semi-constrained, metal/polymer cementedKWSOrthopedic15
Prosthesis, shoulder, semi-constrained, metal/polymer, uncementedMBFOrthopedic0
Prosthesis, spinous process spacer/plateNQOUnknown3
Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrainedPKCOrthopedic0
Prosthesis, tracheal, expandableJCTGeneral, Plastic Surgery4
Prosthesis, vascular graft, of 6mm and greater diameterDSYCardiovascular5
Prosthesis, wrist, 3 part metal-plastic-metal articulation, semi-constrainedJWJOrthopedic0
Prosthesis, wrist, carpal trapeziumKYIOrthopedic1
Protector, ostomyEXEGastroenterology, Urology5
Pulmonary valve prosthesis percutaneously deliveredNPVUnknown4
Pulmonic valved conduitMWHUnknown1
Pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)NKEUnknown16
Pulse generator, permanent, implantableNVZUnknown22
Pulse-generator, pacemaker, externalDTECardiovascular3
Pump, air, non-manual, for endoscopeFEQGastroenterology, Urology4
Pump, blood, cardiopulmonary bypass, non-roller typeKFMCardiovascular6
Pump, blood, cardiopulmonary bypass, roller typeDWBCardiovascular2
Pump, breast, poweredHGXObstetrics/Gynecology9
Pump, infusionFRNGeneral Hospital189
Pump, infusion, elastomericMEBGeneral Hospital11
Pump, infusion, enteralLZHGeneral Hospital11
Pump, infusion, implanted, programmableLKKUnknown16
Pump, infusion, insulinLZGGeneral Hospital71
Pump, infusion, insulin, to be used with invasive glucose sensorOYCUnknown125
Pump, infusion, pcaMEAGeneral Hospital19
Pump, portable, aspiration (manual or powered)BTAGeneral, Plastic Surgery0
Punch, surgicalLRYGeneral, Plastic Surgery0
Radioassay, vitamin b12CDDClinical Chemistry0
Radioimmunoassay, estradiolCHPClinical Chemistry0
Radioimmunoassay, free thyroxineCECClinical Chemistry2
Radioimmunoassay, parathyroid hormoneCEWClinical Chemistry2
Radioimmunoassay, thyroid-stimulating hormoneJLWClinical Chemistry5
Radioimmunoassay, total triiodothyronineCDPClinical Chemistry3
Radioimmunoassay, vancomycinLEHClinical Toxicology0
Reagent red blood cellsQHTHematology0
Reagent, coronavirus serologicalQKOUnknown1
Reagents, 2019-novel coronavirus nucleic acidQJRUnknown22
Real time nucleic acid amplification systemOOIClinical Chemistry2
ReamerHTOOrthopedic38
Recorder, event, implantable cardiac, (with arrhythmia detection)MXDCardiovascular3
Recorder, event, implantable cardiac, (without arrhythmia detection)MXCCardiovascular3
Recorder, magnetic tape, medicalDSHCardiovascular2
Refrigerator, freezer, blood storageKSEHematology0
Regulator, pressure, gas cylinderCANAnesthesiology0
Replacement heart-valveDYECardiovascular16
ResectoscopeFJLGastroenterology, Urology0
Resectoscope, working elementFDCGastroenterology, Urology0
Reservoir, blood, cardiopulmonary bypassDTNCardiovascular0
Resin, root canal fillingKIFDental2
Respiratory virus panel nucleic acid assay systemOCCMicrobiology1
Restraint, protectiveFMQGeneral Hospital0
RetractorGADGeneral, Plastic Surgery0
Ring, annuloplastyKRHCardiovascular10
Rod, fixation, intramedullary and accessoriesHSBOrthopedic21
RongeurHTXOrthopedic0
Rongeur, manualHAENeurology0
Sacroiliac joint fixationOUROrthopedic1
Saline, vascular access flushNGTGeneral Hospital6
Saliva, artificialLFDUnknown0
Saw, powered, and accessoriesHABGeneral, Plastic Surgery5
Scaffold, dissection repairQCTUnknown0
Scaler, ultrasonicELCDental2
Scissors, general, surgicalLRWGeneral, Plastic Surgery0
Scissors, ophthalmicHNFOphthalmic0
Screw, fixation, boneHWCOrthopedic22
Screw, fixation, bone, non-spinal, metallicNDJOrthopedic0
Screw, fixation, intraosseousDZLDental0
ScrewdriverHXXOrthopedic24
Sealant, duralNQRUnknown0
Sealant, polymerizingNBEUnknown0
Sensor, blood-gas, in-line, cardiopulmonary bypassDTYCardiovascular1
Sensor, glucose, implanted, non-adjunctive useQHJUnknown0
Sensor, glucose, invasiveMDSUnknown41
Sensor, glucose, invasive, component of automated insulin delivery systemSFIUnknown2
Sensor, glucose, invasive, non-adjunctivePQFUnknown18
Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiatedPZEUnknown8
Separator, automated, blood cell and plasma, therapeuticLKNUnknown2
Separator, automated, blood cell, diagnosticGKTHematology3
Serology tests used for infectious disease screening of blood and plasma donationsQHMMicrobiology0
Set, administration, for peritoneal dialysis, disposableKDJGastroenterology, Urology19
Set, administration, intravascularFPAGeneral Hospital169
Set, blood transfusionBRZGeneral Hospital2
Set, i.v. fluid transferLHIGeneral Hospital15
Set, tubing and support, ventilator (w harness)BZOAnesthesiology0
Set, tubing, blood, with and without anti-regurgitation valveFJKGastroenterology, Urology6
Shockwave intravascular lithotripsy systemQMGUnknown0
Shoulder prosthesis, reverse configurationPHXOrthopedic5
Shunt, central nervous system and componentsJXGNeurology18
Shunt, portosystemic, endoprosthesisMIRUnknown1
Single (specified) analyte controls (assayed and unassayed)JJXClinical Chemistry0
Single use only blood lancet with an integral sharps injury prevention featureFMKGeneral, Plastic Surgery8
Single-use reprocessed ultrasonic surgical instrumentsNLQUnknown0
Sleeve, limb, compressibleJOWCardiovascular2
Slide stainer, automatedKPAPathology1
Snare, flexibleFDIGastroenterology, Urology5
Snare, non-electricalFGXGastroenterology, Urology1
Solid state x-ray imager (flat panel/digital imager)MQBRadiology0
Source, brachytherapy, radionuclideKXKRadiology0
SphyncteroscopeFDRGastroenterology, Urology0
Spinal pedicle screw, fixation, appliance systemMCVUnknown0
Spinal vertebral body replacement deviceMQPOrthopedic2
Stabilizer, heartMWSCardiovascular1
Stand, infusionFOXGeneral Hospital1
Staple, fixation, boneJDROrthopedic0
Staple, implantableGDWGeneral, Plastic Surgery129
Staple, removable (skin)GDTGeneral, Plastic Surgery4
Stapler, skinQQSGeneral Hospital5
Stapler, surgicalGAGGeneral Hospital27
Station, pipetting and diluting, for clinical useJQWClinical Chemistry0
Stent, carotidNIMUnknown11
Stent, colonic, metallic, expandableMQRGeneral, Plastic Surgery3
Stent, coronaryMAFUnknown26
Stent, iliacNIOUnknown14
Stent, iliac veinQANUnknown3
Stent, metallic, expandable, duodenalMUMGeneral, Plastic Surgery3
Stent, renalNINUnknown1
Stent, superficial femoral arteryNIPUnknown16
Stent, superficial femoral artery, drug-elutingNIUUnknown4
Stent, ureteralFADGastroenterology, Urology11
Stents, drains and dilators for the biliary ductsFGEGastroenterology, Urology41
Sterilant, medical devicesMEDGeneral Hospital2
Sterilization wrap containers, trays, cassettes & other accessoriesKCTGeneral Hospital0
Sterilizer, chemicalMLRGeneral Hospital7
Sterilizer, steamFLEGeneral Hospital1
Stimulator, autonomic nerve, implanted (depression)MUZUnknown1
Stimulator, autonomic nerve, implanted for epilepsyLYJUnknown25
Stimulator, bone growth, non-invasiveLOFOrthopedic2
Stimulator, carotid sinus nerveDSRCardiovascular1
Stimulator, electrical, evoked responseGWFNeurology5
Stimulator, electrical, implantable, for incontinenceEZWGastroenterology, Urology6
Stimulator, electrical, implanted, for essential tremorPJSUnknown0
Stimulator, electrical, implanted, for parkinsonian symptomsNHLUnknown2
Stimulator, electrical, implanted, for parkinsonian tremorMHYUnknown24
Stimulator, hypoglossal nerve, implanted, apneaMNQUnknown4
Stimulator, low electric field, tumor treatmentNZKUnknown2
Stimulator, muscle, poweredIPFPhysical Medicine0
Stimulator, nerveETNEar, Nose, Throat8
Stimulator, nerve, transcutaneous, for pain reliefGZJNeurology0
Stimulator, neuromuscular, lower back muscles, totally implanted for pain reliefQLKUnknown1
Stimulator, peripheral nerve, implanted (pain relief)GZFNeurology4
Stimulator, spinal-cord, implanted (pain relief)GZBNeurology13
Stimulator, spinal-cord, totally implanted for pain reliefLGWUnknown121
Stimulator, thalamic, epilepsy, implantedMBXUnknown0
Stool, operating-roomFZMGeneral, Plastic Surgery1
Stopcock, i.v. setFMGGeneral Hospital2
Stretcher, hand-carriedFPPGeneral Hospital1
Stretcher, wheeledFPOGeneral Hospital44
Stretcher, wheeled, poweredINKPhysical Medicine4
Stylet for catheter, gastro-urologyEZBGastroenterology, Urology2
Stylet, catheterDRBCardiovascular2
Stylet, tracheal tubeBSRAnesthesiology0
Subsystem, water purificationFIPGastroenterology, Urology1
Support, patient positionCCXAnesthesiology1