| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| BST | Curette, Biopsy, Bronchoscope (Non-Rigid) | 第 2 类 | 21 CFR 874.4680 | |
| BTG | Brush, Biopsy, Bronchoscope (Non-Rigid) | 第 2 类 | 21 CFR 874.4680 | 6 |
| BWH | Forceps, Biopsy, Bronchoscope (Non-Rigid) | 第 2 类 | 21 CFR 874.4680 | 6 |
| EMX | Balloon, Epistaxis | 第 1 类 | 21 CFR 874.4100 | 47 |
| ENW | Catheter, Nasopharyngeal | 第 1 类 | 21 CFR 874.4175 | 2 |
| ENZ | Telescope, Laryngeal-Bronchial | 第 2 类 | 21 CFR 874.4680 | 3 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 第 2 类 | 21 CFR 874.4760 | 162 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 第 2 类 | 21 CFR 874.4680 | 241 |
| EOX | Esophagoscope (Flexible Or Rigid) | 第 2 类 | 21 CFR 874.4710 | 30 |
| EPF | Hearing Aid, Group And Auditory Trainer | 第 2 类 | 21 CFR 874.3320 | 32 |
| EPN | Pump, Nebulizer, Manual | 第 1 类 | 21 CFR 874.5220 | 2 |
| EPP | Splint, Nasal | 第 1 类 | 21 CFR 874.5800 | 15 |
| EQH | Source, Carrier, Fiberoptic Light | 第 1 类 | 21 CFR 874.4350 | 49 |
| EQJ | Bur, Ear, Nose And Throat | 第 1 类 | 21 CFR 874.4140 | 18 |
| EQL | Laryngostroboscope | 第 1 类 | 21 CFR 874.4750 | 8 |
| EQN | Laryngoscope, Nasopharyngoscope | 第 2 类 | 21 CFR 874.4760 | 22 |
| ERA | Otoscope | 第 1 类 | 21 CFR 874.4770 | 56 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 第 2 类 | 21 CFR 874.4250 | 91 |
| ESD | Hearing Aid, Air-Conduction, Prescription | 第 1 类 | 21 CFR 874.3300 | 1367 |
| ESE | Larynx, Artificial (Battery-Powered) | 第 1 类 | 21 CFR 874.3375 | 13 |
| ESH | Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyuret | 第 2 类 | 21 CFR 874.3620 | 1 |
| ESX | Tack, Sacculotomy (Cody Tack) | 第 2 类 | 21 CFR 874.3760 | 1 |
| ESZ | Tube, Shunt, Endolymphatic | 第 2 类 | 21 CFR 874.3820 | 4 |
| ETA | Replacement, Ossicular Prosthesis, Total | 第 2 类 | 21 CFR 874.3495 | 39 |
| ETB | Prosthesis, Partial Ossicular Replacement | 第 2 类 | 21 CFR 874.3450 | 74 |
| ETC | Mold, Middle-Ear | 第 2 类 | 21 CFR 874.3430 | 1 |
| ETD | Tube, Tympanostomy | 第 2 类 | 21 CFR 874.3880 | 116 |
| ETF | Unit, Examining/Treatment, Ent | 第 1 类 | 21 CFR 874.5300 | 32 |
| ETK | Tube, Toynbee Diagnostic | 第 1 类 | 21 CFR 874.1925 | 1 |
| ETM | Gustometer, Sterile | 第 1 类 | 21 CFR 874.1500 | |
| ETN | Stimulator, Nerve | 第 2 类 | 21 CFR 874.1820 | 97 |
| ETP | Stimulator, Caloric-Water | 第 1 类 | 21 CFR 874.1800 | 6 |
| ETR | Adaptor, Short Increment Sensitivity Index (Sisi) | 第 1 类 | 21 CFR 874.1070 | |
| ETS | Generator, Electronic Noise (For Audiometric Testing) | 第 2 类 | 21 CFR 874.1120 | 5 |
| ETT | Cushion, Earphone (For Audiometric Testing) | 第 1 类 | 21 CFR 874.1100 | |
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | 第 2 类 | 21 CFR 874.3310 | 46 |
| ETY | Tester, Auditory Impedance | 第 2 类 | 21 CFR 874.1090 | 70 |
| EWA | Set, Audiometer Calibration | 第 1 类 | 21 CFR 874.1080 | 2 |
| EWC | Chamber, Acoustic (For Audiometric Testing) | 第 1 类 | 21 CFR 874.1060 | 2 |
| EWG | Laser, Ent Microsurgical Carbon-Dioxide | 第 2 类 | 21 CFR 874.4500 | 24 |
| EWL | Prosthesis, Laryngeal (Taub) | 第 2 类 | 21 CFR 874.3730 | 40 |
| EWO | Audiometer | 第 2 类 | 21 CFR 874.1050 | 235 |
| EWQ | Saw, Surgical, Ent (Electric Or Pneumatic) | 第 1 类 | 21 CFR 874.4420 | 2 |
| EWT | Device, Antichoke, Suction | 第 3 类 | 21 CFR 874.5350 | |
| EWW | Device, Antichoke, Tongs | 第 3 类 | 21 CFR 874.5370 | |
| EWY | Mediastinoscope, Surgical | 第 2 类 | 21 CFR 874.4720 | 11 |
| FWN | Prosthesis, Larynx (Stents And Keels) | 第 2 类 | 21 CFR 874.3620 | 10 |
| JAZ | Prosthesis, Facial, Mandibular Implant | 第 2 类 | 21 CFR 874.3695 | 2 |
| JEI | Claw, Foreign Body, Bronchoscope (Non-Rigid) | 第 2 类 | 21 CFR 874.4680 | |
| JEJ | Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating) | 第 2 类 | 21 CFR 874.4680 | 2 |
| JEK | Forceps, Biopsy, Bronchoscope (Rigid) | 第 2 类 | 21 CFR 874.4680 | 3 |
| JEL | Curette, Biopsy, Bronchoscope (Rigid) | 第 2 类 | 21 CFR 874.4680 | 1 |
| JOF | Polymer, Ent Synthetic, Porous Polyethylene | 第 2 类 | 21 CFR 874.3620 | 6 |
| JPW | Pump, Nebulizer, Electrically Powered | 第 1 类 | 21 CFR 874.5220 | 1 |
| JXS | Block, Cutting, Ent, Sterile | 第 1 类 | 21 CFR 874.3540 | 2 |
| JXT | Crimper, Wire, Ent, Sterile | 第 1 类 | 21 CFR 874.3540 | |
| JXW | Die, Wire Bending, Ent, Sterile | 第 1 类 | 21 CFR 874.3540 | |
| JXX | Forceps, Wire Closure, Ent, Sterile | 第 1 类 | 21 CFR 874.3540 | |
| JXY | Jig, Piston Cutting, Ent, Sterile | 第 1 类 | 21 CFR 874.3540 | |
| JXZ | Punch, Gelfoam, Sterile | 第 1 类 | 21 CFR 874.3540 | |
| JYA | Scissors, Wire Cutting, Ent, Sterile | 第 1 类 | 21 CFR 874.3540 | |
| JYB | Vise, Ossicular Finger, Sterile | 第 1 类 | 21 CFR 874.3540 | |
| JYE | Chisel, Middle-Ear | 第 1 类 | 21 CFR 874.4420 | 1 |
| JYF | Clamp, Ossicle Holding | 第 1 类 | 21 CFR 874.4420 | |
| JYG | Curette, Ear | 第 1 类 | 21 CFR 874.4420 | 7 |
| JYH | Excavator, Ear | 第 1 类 | 21 CFR 874.4420 | |
| JYI | Gauge, Mastoid | 第 1 类 | 21 CFR 874.4420 | |
| JYJ | Gauge, Measuring | 第 1 类 | 21 CFR 874.4420 | 5 |
| JYL | Hook, Microsurgical Ear | 第 1 类 | 21 CFR 874.4420 | 5 |
| JYM | Inserter, Myringotomy Tube | 第 1 类 | 21 CFR 874.4420 | 4 |
| JYN | Inserter, Sacculotomy Tack | 第 1 类 | 21 CFR 874.4420 | |
| JYO | Knife, Ear | 第 1 类 | 21 CFR 874.4420 | 7 |
| JYP | Knife, Myringotomy | 第 1 类 | 21 CFR 874.4420 | 1 |
| JYQ | Loop, Wire | 第 1 类 | 21 CFR 874.4420 | 2 |
| JYR | Nipper, Malleus | 第 1 类 | 21 CFR 874.4420 | 2 |
| JYS | Perforator, Ear-Lobe | 第 1 类 | 21 CFR 874.4420 | 3 |
| JYT | Pick, Microsurgical Ear | 第 1 类 | 21 CFR 874.4420 | 2 |
| JYW | Press, Vein | 第 1 类 | 21 CFR 874.4420 | 1 |
| JYX | Punch, Attic | 第 1 类 | 21 CFR 874.4420 | |
| JYY | Rasp, Ear | 第 1 类 | 21 CFR 874.4420 | 1 |
| JYZ | Rod, Measuring Ear | 第 1 类 | 21 CFR 874.4420 | 1 |
| JZA | Rongeur, Mastoid | 第 1 类 | 21 CFR 874.4420 | 1 |
| JZB | Scissors, Ear | 第 1 类 | 21 CFR 874.4420 | 4 |
| JZC | Searcher, Mastoid | 第 1 类 | 21 CFR 874.4420 | |
| JZD | Snare, Ear | 第 1 类 | 21 CFR 874.4420 | 2 |
| JZE | Spoon, Ear | 第 1 类 | 21 CFR 874.4420 | 1 |
| JZF | Tube, Ear Suction | 第 1 类 | 21 CFR 874.4420 | 5 |
| JZY | Knife, Laryngeal | 第 1 类 | 21 CFR 874.4420 | |
| JZZ | Saw, Laryngeal | 第 1 类 | 21 CFR 874.4420 | |
| KAA | Set, Laryngeal Injection | 第 1 类 | 21 CFR 874.4420 | |
| KAB | Trocar, Laryngeal | 第 1 类 | 21 CFR 874.4420 | 1 |
| KAC | Tube, Laryngectomy | 第 1 类 | 21 CFR 874.4420 | 4 |
| KAD | Elevator, Ent | 第 1 类 | 21 CFR 874.4420 | 5 |
| KAE | Forceps, Ent | 第 1 类 | 21 CFR 874.4420 | 14 |
| KAH | Microrule, Ent | 第 1 类 | 21 CFR 874.4420 | |
| KAI | Mirror, Ent | 第 1 类 | 21 CFR 874.4420 | 9 |
| KAJ | Mobilizer, Ent | 第 1 类 | 21 CFR 874.4420 | |
| KAK | Probe, Ent | 第 1 类 | 21 CFR 874.4420 | 1 |
| KAL | Retractor, Ent | 第 1 类 | 21 CFR 874.4420 | 5 |
| KAO | Curette, Ethmoid | 第 1 类 | 21 CFR 874.4420 | |
| KAP | Curette, Nasal | 第 1 类 | 21 CFR 874.4420 | 1 |
| KAQ | Gouge, Nasal, Ent | 第 1 类 | 21 CFR 874.4420 | |
| KAR | Irrigator, Sinus | 第 1 类 | 21 CFR 874.4420 | 3 |
| KAS | Knife, Nasal | 第 1 类 | 21 CFR 874.4420 | 1 |
| KAT | Perforator, Antrum | 第 1 类 | 21 CFR 874.4420 | |
| KAW | Punch, Antrum | 第 1 类 | 21 CFR 874.4420 | |
| KAX | Punch, Ethmoid | 第 1 类 | 21 CFR 874.4420 | |
| KAY | Punch, Nasal | 第 1 类 | 21 CFR 874.4420 | |
| KAZ | Rasp, Frontal-Sinus | 第 1 类 | 21 CFR 874.4420 | |
| KBA | Rasp, Nasal | 第 1 类 | 21 CFR 874.4420 | |
| KBB | Rongeur, Nasal | 第 1 类 | 21 CFR 874.4420 | |
| KBC | Saw, Nasal | 第 1 类 | 21 CFR 874.4420 | 4 |
| KBD | Scissors, Nasal | 第 1 类 | 21 CFR 874.4420 | 3 |
| KBE | Snare, Nasal | 第 1 类 | 21 CFR 874.4420 | |
| KBF | Trephine, Sinus | 第 1 类 | 21 CFR 874.4420 | 1 |
| KBG | Trocar, Sinus | 第 1 类 | 21 CFR 874.4420 | 3 |
| KBH | Adenotome | 第 1 类 | 21 CFR 874.4420 | 1 |
| KBI | Bougie, Eustachian | 第 1 类 | 21 CFR 874.4175 | 1 |
| KBJ | Curette, Adenoid | 第 1 类 | 21 CFR 874.4420 | 1 |
| KBK | Curette, Salpingeal | 第 1 类 | 21 CFR 874.4420 | |
| KBL | Depressor, Metal Tongue, Surgical | 第 1 类 | 21 CFR 874.4420 | 1 |
| KBM | Dissector, Tonsil | 第 1 类 | 21 CFR 874.4420 | 1 |
| KBN | Gag, Mouth | 第 1 类 | 21 CFR 874.4420 | 3 |
| KBO | Guillotine, Tonsil | 第 1 类 | 21 CFR 874.4420 | 1 |
| KBP | Hook, Tonsil Suturing | 第 1 类 | 21 CFR 874.4420 | |
| KBQ | Knife, Tonsil | 第 1 类 | 21 CFR 874.4420 | 1 |
| KBR | Needle, Tonsil Suturing | 第 1 类 | 21 CFR 874.4420 | |
| KBS | Punch, Adenoid | 第 1 类 | 21 CFR 874.4420 | |
| KBT | Punch, Tonsil | 第 1 类 | 21 CFR 874.4420 | |
| KBW | Screw, Oral | 第 1 类 | 21 CFR 874.4420 | 1 |
| KBX | Screw, Tonsil | 第 1 类 | 21 CFR 874.4420 | |
| KBY | Set, Filliform, Eustachian | 第 1 类 | 21 CFR 874.4175 | |
| KBZ | Snare, Tonsil | 第 1 类 | 21 CFR 874.4420 | 1 |
| KCA | Tonsillectome | 第 1 类 | 21 CFR 874.4420 | 1 |
| KCB | Tube, Tonsil Suction | 第 1 类 | 21 CFR 874.4420 | 1 |
| KCC | Bistoury, Tracheal | 第 1 类 | 21 CFR 874.4420 | |
| KCD | Bougie, Esophageal, Ent | 第 1 类 | 21 CFR 874.4420 | 3 |
| KCF | Dilator, Esophageal, Ent | 第 1 类 | 21 CFR 874.4420 | 3 |
| KCG | Dilator, Tracheal | 第 1 类 | 21 CFR 874.4420 | 1 |
| KCH | Hook, Tracheal | 第 1 类 | 21 CFR 874.4420 | |
| KCI | Trocar, Tracheal | 第 1 类 | 21 CFR 874.4420 | |
| KCJ | Applicator, Ent | 第 1 类 | 21 CFR 874.5220 | 4 |
| KCL | Blower, Powder, Ent | 第 1 类 | 21 CFR 874.5220 | |
| KCM | Dropper, Ent | 第 1 类 | 21 CFR 874.5220 | 1 |
| KCN | Ear Wick | 第 1 类 | 21 CFR 874.5220 | 4 |
| KCO | Nasal Spray, Ent Delivery | 第 1 类 | 21 CFR 874.5220 | 1 |
| KCP | Syringe, Ent | 第 1 类 | 21 CFR 874.5220 | 4 |
| KHH | Stimulator, Caloric-Air | 第 1 类 | 21 CFR 874.1800 | 7 |
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | 第 2 类 | 21 CFR 874.3620 | 34 |
| KHL | Hearing Aid, Master | 第 2 类 | 21 CFR 874.3330 | 7 |
| KLW | Masker, Tinnitus | 第 2 类 | 21 CFR 874.3400 | 78 |
| KLX | Electroglottograph | 第 2 类 | 21 CFR 874.1325 | 4 |
| KLZ | Tube, Shunt, Endolymphatic With Valve | 第 2 类 | 21 CFR 874.3850 | 1 |
| KMA | Irrigator, Powered Nasal | 第 1 类 | 21 CFR 874.5550 | 5 |
| KQL | Tube, Tympanostomy With Semi-Permeable Membrane | 第 2 类 | 21 CFR 874.3930 | |
| KTE | Trocar, Ent | 第 1 类 | 21 CFR 874.4420 | 1 |
| KTF | Punch, Ent | 第 1 类 | 21 CFR 874.4420 | |
| KTG | Knife, Ent | 第 1 类 | 21 CFR 874.4420 | 5 |
| KTH | Device, Anti-Stammering | 第 1 类 | 21 CFR 874.5840 | 4 |
| KTI | Bronchoscope Accessory | 第 2 类 | 21 CFR 874.4680 | 34 |
| KTR | Tube, Aspirating, Bronchoscope, Rigid | 第 2 类 | 21 CFR 874.4680 | 4 |
| LBL | Tube, Tympanostomy, Porous Polyethylene | 第 2 类 | 21 CFR 874.3880 | 1 |
| LBM | Porous Polyethylene Ossicular Replacement | 第 2 类 | 21 CFR 874.3450 | 2 |
| LBN | Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene | 第 2 类 | 21 CFR 874.3495 | 1 |
| LBP | Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material | 第 2 类 | 21 CFR 874.3450 | |
| LDG | Kit, Earmold, Impression | 第 1 类 | 21 CFR 874.3300 | 2 |
| LJW | Tracheotome | 第 1 类 | 21 CFR 874.4420 | 2 |
| LLO | Laser, Neodymium:Yag, Pulmonary Surgery | 第 2 类 | 21 CFR 874.4500 | 19 |
| LMS | Laser, Microsurgical Argon, For Uses Other Than Otology, Including Lar | 第 2 类 | 21 CFR 874.4490 | 2 |
| LRB | Face Plate Hearing Aid | 第 1 类 | 21 CFR 874.3300 | 24 |
| LRC | Instrument, Ent Manual Surgical | 第 1 类 | 21 CFR 874.4420 | 65 |
| LRD | Applicator, Ent Drug | 第 1 类 | 21 CFR 874.5220 | 6 |
| LRE | Instrument, Prosthesis Modification For Ossicular Replacement Surgery, | 第 1 类 | 21 CFR 874.3540 | |
| LWF | Dilator, Nasal | 第 1 类 | 21 CFR 874.3900 | 20 |
| LXB | Hearing Aid, Bone Conduction | 第 2 类 | 21 CFR 874.3302 | 53 |
| LXR | Laser, Microsurgical Argon, For Use In Otology | 第 2 类 | 21 CFR 874.4490 | |
| LYA | Splint, Intranasal Septal | 第 1 类 | 21 CFR 874.4780 | 46 |
| LYN | Apparatus, Visual Reinforcement Audiometric | 第 2 类 | 21 CFR 874.1050 | 3 |
| LZI | Device, Assistive Listening | 第 2 类 | 21 CFR 874.3320 | 7 |
| MAH | Hearing Aid, Bone Conduction, Implanted | 第 2 类 | 21 CFR 874.3302 | 12 |
| MCK | Device, Voice Amplification | 第 2 类 | 21 CFR 874.3730 | |
| MIB | Elastomer, Silicone Block | 第 2 类 | 21 CFR 874.3620 | 45 |
| MIC | Implant, Muscle, Pectoralis | 第 2 类 | 21 CFR 874.3620 | 8 |
| MIX | System, Vocal Cord Medialization | 第 2 类 | 21 CFR 874.3620 | 17 |
| MMO | Tray, Surgical, Ent | 第 1 类 | 21 CFR 874.4420 | 1 |
| MQW | Transilluminator, Fiber Optic | 第 1 类 | 21 CFR 874.4350 | 1 |
| MXP | Bone Particle Collector | 第 1 类 | 21 CFR 874.4800 | |
| NAS | Tympanometer | 第 2 类 | 21 CFR 874.1090 | 2 |
| NHB | Polymer, Ear, Nose And Throat, Synthetic, Absorbable | 第 2 类 | 21 CFR 874.3620 | 16 |
| NIX | Hearing Aid, Air Conduction, Transcutaneous System | 第 2 类 | 21 CFR 874.3950 | 2 |
| NLB | Trocar, Tracheal, Laryngeal, Sinus, Reprocessed | 第 1 类 | 21 CFR 874.4420 | |
| NLE | Forceps, Biopsy, Bronchoscope (Non-Rigid), Reprocessed | 第 2 类 | 21 CFR 874.4680 | |
| NLY | Microdebrider, Ent, High Speed, Single Use, Reprocessed | 第 1 类 | 21 CFR 874.4140 | 1 |
| NLZ | Bur, Ent, Diamond Coated, Single Use, Reprocessed | 第 1 类 | 21 CFR 874.4140 | |
| NNJ | Gustometer, Non-Sterile | 第 1 类 | 21 CFR 874.1500 | |
| NNN | Crimper, Wire, Ent, Non-Sterile | 第 1 类 | 21 CFR 874.3540 | |
| NNO | Jig, Piston Cutting, Ent, Non-Sterile | 第 1 类 | 21 CFR 874.3540 | |
| NNP | Die, Wire Bending, Ent, Non-Sterile | 第 1 类 | 21 CFR 874.3540 | |
| NNQ | Forceps, Wire Closure, Ent, Non-Sterile | 第 1 类 | 21 CFR 874.3540 | |
| NNR | Block, Cutting, Ent, Non-Sterile | 第 1 类 | 21 CFR 874.3540 | |