Ear, Nose, Throat

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CodeDevice nameClass21 CFR510(k) (3y)
NNSInstrument, Prosthesis Modification For Ossicular Replacement Surgery,Class 121 CFR 874.3540
NNTPunch, Gelfoam, Non-SterileClass 121 CFR 874.3540
NNUScissors, Wire Cutting, Ent, Non-SterileClass 121 CFR 874.3540
NNVVise, Ossicular Finger, Non-SterileClass 121 CFR 874.3540
NRKKit, Test, OlfactoryClass 221 CFR 874.16001
OGREar, Nose, And Throat Surgical TrayClass 121 CFR 874.4420
OGSMyringotomy Procedure KitClass 221 CFR 874.3880
OGUPierced Ear/Entry Cleaning TrayClass 121 CFR 874.4420
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionClass 221 CFR 874.33051
PDQNeurosurgical Nerve LocatorClass 221 CFR 874.182036
PFOActive Implantable Bone Conduction Hearing SystemClass 221 CFR 874.334012
PKAExternal Upper Esophageal Sphincter (Ues) Compression DeviceClass 221 CFR 874.59002
PLKTympanic Membrane Direct Contact Hearing AidClass 221 CFR 874.33153
PNZEustachian Tube Balloon Dilation DeviceClass 221 CFR 874.41809
PTOTester, Auditory Impedance, ExemptClass 221 CFR 874.1090
PTPTympanometer, ExemptClass 221 CFR 874.1090
QDDSelf-Fitting Air-Conduction Hearing Aid, PrescriptionClass 221 CFR 874.33257
QGKBalloon, Nasal AirwayClass 121 CFR 874.44201
QJLSplint, Intranasal Septal, Cber LedClass 121 CFR 874.47801
QNUTranscutaneous Electrical Nerve Stimulator For The Relief Of CongestioClass 221 CFR 874.60001
QNWReprocessed BronchoscopeClass 221 CFR 874.46802
QQGOropharyngeal Electrical StimulatorClass 221 CFR 874.59501
QQHPowered Insertion System For A Cochlear Implant Electrode ArrayClass 221 CFR 874.44502
QRSDevice For Sleep Apnea Testing Based On Mandibular MovementClass 221 CFR 868.23763
QUFHearing Aid, Air-Conduction, Over The CounterClass 121 CFR 874.3300
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The CounterClass 221 CFR 874.3305
QUHSelf-Fitting Air-Conduction Hearing Aid, Over The CounterClass 221 CFR 874.332510
QVNCombined Acoustic And Electrical External Stimulation Device For The RClass 221 CFR 874.34101
QWPOptical Neurosurgical Nerve LocatorClass 221 CFR 874.18201
QXGCooperative Powered Surgical Assist Device For Ent SurgeryClass 221 CFR 874.44601
QXNSuction Anti-Choking Device As A Second-Line TreatmentClass 221 CFR 874.54001
QZCExternal Mechanical Stimulator For The Relief Of CongestionClass 221 CFR 874.60102
SBSLaryngeal Injection Set With Led LightClass 121 CFR 874.44201
SCRAir-Conduction Hearing Aid SoftwareClass 221 CFR 874.33355
SHLEar, Nose, And Throat Image AnalyzerClass 221 CFR 874.47751