| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| NNS | Instrument, Prosthesis Modification For Ossicular Replacement Surgery, | 第 1 类 | 21 CFR 874.3540 | |
| NNT | Punch, Gelfoam, Non-Sterile | 第 1 类 | 21 CFR 874.3540 | |
| NNU | Scissors, Wire Cutting, Ent, Non-Sterile | 第 1 类 | 21 CFR 874.3540 | |
| NNV | Vise, Ossicular Finger, Non-Sterile | 第 1 类 | 21 CFR 874.3540 | |
| NRK | Kit, Test, Olfactory | 第 2 类 | 21 CFR 874.1600 | 1 |
| OGR | Ear, Nose, And Throat Surgical Tray | 第 1 类 | 21 CFR 874.4420 | |
| OGS | Myringotomy Procedure Kit | 第 2 类 | 21 CFR 874.3880 | |
| OGU | Pierced Ear/Entry Cleaning Tray | 第 1 类 | 21 CFR 874.4420 | |
| OSM | Hearing Aid, Air-Conduction With Wireless Technology, Prescription | 第 2 类 | 21 CFR 874.3305 | 1 |
| PDQ | Neurosurgical Nerve Locator | 第 2 类 | 21 CFR 874.1820 | 36 |
| PFO | Active Implantable Bone Conduction Hearing System | 第 2 类 | 21 CFR 874.3340 | 12 |
| PKA | External Upper Esophageal Sphincter (Ues) Compression Device | 第 2 类 | 21 CFR 874.5900 | 2 |
| PLK | Tympanic Membrane Direct Contact Hearing Aid | 第 2 类 | 21 CFR 874.3315 | 3 |
| PNZ | Eustachian Tube Balloon Dilation Device | 第 2 类 | 21 CFR 874.4180 | 9 |
| PTO | Tester, Auditory Impedance, Exempt | 第 2 类 | 21 CFR 874.1090 | |
| PTP | Tympanometer, Exempt | 第 2 类 | 21 CFR 874.1090 | |
| QDD | Self-Fitting Air-Conduction Hearing Aid, Prescription | 第 2 类 | 21 CFR 874.3325 | 7 |
| QGK | Balloon, Nasal Airway | 第 1 类 | 21 CFR 874.4420 | 1 |
| QJL | Splint, Intranasal Septal, Cber Led | 第 1 类 | 21 CFR 874.4780 | 1 |
| QNU | Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestio | 第 2 类 | 21 CFR 874.6000 | 1 |
| QNW | Reprocessed Bronchoscope | 第 2 类 | 21 CFR 874.4680 | 2 |
| QQG | Oropharyngeal Electrical Stimulator | 第 2 类 | 21 CFR 874.5950 | 1 |
| QQH | Powered Insertion System For A Cochlear Implant Electrode Array | 第 2 类 | 21 CFR 874.4450 | 2 |
| QRS | Device For Sleep Apnea Testing Based On Mandibular Movement | 第 2 类 | 21 CFR 868.2376 | 3 |
| QUF | Hearing Aid, Air-Conduction, Over The Counter | 第 1 类 | 21 CFR 874.3300 | |
| QUG | Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | 第 2 类 | 21 CFR 874.3305 | |
| QUH | Self-Fitting Air-Conduction Hearing Aid, Over The Counter | 第 2 类 | 21 CFR 874.3325 | 10 |
| QVN | Combined Acoustic And Electrical External Stimulation Device For The R | 第 2 类 | 21 CFR 874.3410 | 1 |
| QWP | Optical Neurosurgical Nerve Locator | 第 2 类 | 21 CFR 874.1820 | 1 |
| QXG | Cooperative Powered Surgical Assist Device For Ent Surgery | 第 2 类 | 21 CFR 874.4460 | 1 |
| QXN | Suction Anti-Choking Device As A Second-Line Treatment | 第 2 类 | 21 CFR 874.5400 | 1 |
| QZC | External Mechanical Stimulator For The Relief Of Congestion | 第 2 类 | 21 CFR 874.6010 | 2 |
| SBS | Laryngeal Injection Set With Led Light | 第 1 类 | 21 CFR 874.4420 | 1 |
| SCR | Air-Conduction Hearing Aid Software | 第 2 类 | 21 CFR 874.3335 | 5 |
| SHL | Ear, Nose, And Throat Image Analyzer | 第 2 类 | 21 CFR 874.4775 | 1 |