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- 21 CFR 874.1090 · Auditory impedance tester.
- 21 CFR 874.1100 · Earphone cushion for audiometric testing.
- 21 CFR 874.1120 · Electronic noise generator for audiometric testing.
- 21 CFR 874.1325 · Electroglottograph.
- 21 CFR 874.1500 · Gustometer.
- 21 CFR 874.1600 · Olfactory test device.
- 21 CFR 874.1800 · Air or water caloric stimulator.
- 21 CFR 874.1820 · Surgical nerve stimulator/locator.
- 21 CFR 874.1925 · Toynbee diagnostic tube.
- 21 CFR 874.3300 · Air-conduction hearing aid.
- 21 CFR 874.3302 · Bone-conduction hearing aid.
- 21 CFR 874.3305 · Wireless air-conduction hearing aid.
- 21 CFR 874.3310 · Hearing aid calibrator and analysis system.
- 21 CFR 874.3315 · Tympanic membrane contact hearing aid.
- 21 CFR 874.3320 · Group hearing aid or group auditory trainer.
- 21 CFR 874.3325 · Self-fitting air-conduction hearing aid.
- 21 CFR 874.3330 · Master hearing aid.
- 21 CFR 874.3340 · Active implantable bone conduction hearing system.
- 21 CFR 874.3375 · Battery-powered artificial larynx.
- 21 CFR 874.3400 · Tinnitus masker.
- 21 CFR 874.3410 · Combined acoustic and electrical external stimulation device for the relief of tinnitus.
- 21 CFR 874.3430 · Middle ear mold.
- 21 CFR 874.3450 · Partial ossicular replacement prosthesis.
- 21 CFR 874.3495 · Total ossicular replacement prosthesis.
- 21 CFR 874.3540 · Prosthesis modification instrument for ossicular replacement surgery.
- 21 CFR 874.3620 · Ear, nose, and throat synthetic polymer material.
- 21 CFR 874.3695 · Mandibular implant facial prosthesis.
- 21 CFR 874.3730 · Laryngeal prosthesis (Taub design).
- 21 CFR 874.3760 · Sacculotomy tack (Cody tack)
- 21 CFR 874.3820 · Endolymphatic shunt.
- 21 CFR 874.3850 · Endolymphatic shunt tube with valve.
- 21 CFR 874.3880 · Tympanostomy tube.
- 21 CFR 874.3900 · Nasal dilator.
- 21 CFR 874.3930 · Tympanostomy tube with semipermeable membrane.
- 21 CFR 874.3950 · Transcutaneous air conduction hearing aid system.
- 21 CFR 874.4100 · Epistaxis balloon.
- 21 CFR 874.4140 · Ear, nose, and throat bur.
- 21 CFR 874.4175 · Nasopharyngeal catheter.
- 21 CFR 874.4180 · Eustachian tube balloon dilation system.
- 21 CFR 874.4250 · Ear, nose, and throat electric or pneumatic surgical drill.
- 21 CFR 874.4350 · Ear, nose, and throat fiberoptic light source and carrier.
- 21 CFR 874.4420 · Ear, nose, and throat manual surgical instrument.
- 21 CFR 874.4450 · Powered insertion system for a cochlear implant electrode array.
- 21 CFR 874.4460 · Cooperative powered surgical assist device for ENT surgery.
- 21 CFR 874.4490 · Argon laser for otology, rhinology, and laryngology.
- 21 CFR 874.4500 · Ear, nose, and throat microsurgical carbon dioxide laser.
- 21 CFR 874.4680 · Bronchoscope (flexible or rigid) and accessories.
- 21 CFR 874.4710 · Esophagoscope (flexible or rigid) and accessories.
- 21 CFR 874.4720 · Mediastinoscope and accessories.
- 21 CFR 874.4750 · Laryngostroboscope.
- 21 CFR 874.4760 · Nasopharyngoscope (flexible or rigid) and accessories.
- 21 CFR 874.4770 · Otoscope.
- 21 CFR 874.4780 · Intranasal splint.
- 21 CFR 874.4800 · Bone particle collector.
- 21 CFR 874.5220 · Ear, nose, and throat drug administration device.
- 21 CFR 874.5300 · Ear, nose, and throat examination and treatment unit.
- 21 CFR 874.5350 · Suction antichoke device.
- 21 CFR 874.5370 · Tongs antichoke device.
- 21 CFR 874.5550 · Powered nasal irrigator.
- 21 CFR 874.5800 · External nasal splint.
- 21 CFR 874.5840 · Antistammering device.
- 21 CFR 874.5900 · External upper esophageal sphincter compression device.
- 21 CFR 874.5950 · Oropharyngeal electrical stimulator.
- 21 CFR 874.6000 · Transcutaneous electrical nerve stimulator for the relief of congestion.
- 21 CFR 876.1 · Scope.
- 21 CFR 876.3 · Effective dates of requirement for premarket approval.
- 21 CFR 876.9 · Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
- 21 CFR 876.1050 · Endoscopic transhepatic venous access needle.
- 21 CFR 876.1075 · Gastroenterology-urology biopsy instrument.
- 21 CFR 876.1080 · Gastroenterology-urology accessories to a biopsy instrument.
- 21 CFR 876.1300 · Ingestible telemetric gastrointestinal capsule imaging system.
- 21 CFR 876.1310 · Magnetically maneuvered capsule endoscopy system.
- 21 CFR 876.1330 · Colon capsule endoscopy system.
- 21 CFR 876.1390 · Ingestible gastrointestinal blood detection capsule.
- 21 CFR 876.1400 · Stomach pH electrode.
- 21 CFR 876.1450 · Esophageal tissue characterization system.
- 21 CFR 876.1500 · Endoscope and accessories.
- 21 CFR 876.1510 · Anchored esophageal sheath.
- 21 CFR 876.1520 · Gastrointestinal lesion software detection system.
- 21 CFR 876.1530 · Endoscopic light-projecting measuring device.
- 21 CFR 876.1620 · Urodynamics measurement system.
- 21 CFR 876.1725 · Gastrointestinal motility monitoring system.
- 21 CFR 876.1735 · Electrogastrography system.
- 21 CFR 876.1800 · Urine flow or volume measuring system.
- 21 CFR 876.2040 · Enuresis alarm.
- 21 CFR 876.2050 · Prostate lesion documentation system.
- 21 CFR 876.2100 · Pressure ulcer management tool.
- 21 CFR 876.3350 · Penile inflatable implant.
- 21 CFR 876.3500 · Penile implant surgical accessories.
- 21 CFR 876.3630 · Penile rigidity implant.
- 21 CFR 876.3750 · Testicular prosthesis.
- 21 CFR 876.4020 · Fiberoptic light ureteral catheter.
- 21 CFR 876.4100 · Flushing and storage solution for vascular autografts at room temperature.
- 21 CFR 876.4270 · Colostomy rod.
- 21 CFR 876.4300 · Endoscopic electrosurgical unit and accessories.
- 21 CFR 876.4310 · Endoscopic electrosurgical clip cutting system.
- 21 CFR 876.4330 · Endoscopic pancreatic debridement device.
- 21 CFR 876.4340 · High intensity ultrasound system for prostate tissue ablation.
- 21 CFR 876.4350 · Fluid jet system for prostate tissue removal.
- 21 CFR 876.4370 · Gastroenterology-urology evacuator.