| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| GWE | Stimulator, Photic, Evoked Response | 第 2 类 | 21 CFR 882.1890 | 49 |
| GWF | Stimulator, Electrical, Evoked Response | 第 2 类 | 21 CFR 882.1870 | 140 |
| GWG | Endoscope, Neurological | 第 2 类 | 21 CFR 882.1480 | 93 |
| GWI | Discriminator, Two-Point | 第 1 类 | 21 CFR 882.1200 | 2 |
| GWJ | Stimulator, Auditory, Evoked Response | 第 2 类 | 21 CFR 882.1900 | 76 |
| GWK | Conditioner, Signal, Physiological | 第 2 类 | 21 CFR 882.1845 | 23 |
| GWL | Amplifier, Physiological Signal | 第 2 类 | 21 CFR 882.1835 | 53 |
| GWM | Device, Monitoring, Intracranial Pressure | 第 2 类 | 21 CFR 882.1620 | 105 |
| GWN | Nystagmograph | 第 2 类 | 21 CFR 882.1460 | 60 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | 第 2 类 | 21 CFR 882.5320 | 43 |
| GWQ | Full-Montage Standard Electroencephalograph | 第 2 类 | 21 CFR 882.1400 | 189 |
| GWR | Generator, Electroencephalograph Test Signal | 第 1 类 | 21 CFR 882.1430 | |
| GWS | Analyzer, Spectrum, Electroencephalogram Signal | 第 1 类 | 21 CFR 882.1420 | 15 |
| GWW | Ataxiagraph | 第 1 类 | 21 CFR 882.1030 | |
| GWX | Fork, Tuning | 第 1 类 | 21 CFR 882.1525 | 4 |
| GWY | Pinwheel | 第 1 类 | 21 CFR 882.1750 | 5 |
| GWZ | Percussor | 第 1 类 | 21 CFR 882.1700 | 11 |
| GXB | Esthesiometer | 第 1 类 | 21 CFR 882.1500 | 7 |
| GXC | Device, Electroconvulsive Therapy | 第 3 类 | 21 CFR 882.5940 | |
| GXD | Generator, Lesion, Radiofrequency | 第 2 类 | 21 CFR 882.4400 | 37 |
| GXE | Leukotome | 第 1 类 | 21 CFR 882.4600 | 1 |
| GXH | Device, Surgical, Cryogenic | 第 2 类 | 21 CFR 882.4250 | 23 |
| GXI | Probe, Radiofrequency Lesion | 第 2 类 | 21 CFR 882.4725 | 66 |
| GXJ | Punch, Skull | 第 1 类 | 21 CFR 882.4750 | |
| GXL | Screwdriver, Skullplate | 第 1 类 | 21 CFR 882.4900 | |
| GXM | Anvil, Skull Plate | 第 1 类 | 21 CFR 882.4030 | |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 第 2 类 | 21 CFR 882.5330 | 57 |
| GXO | Strip, Craniosynostosis, Preformed | 第 2 类 | 21 CFR 882.5900 | 2 |
| GXP | Methyl Methacrylate For Cranioplasty | 第 2 类 | 21 CFR 882.5300 | 45 |
| GXQ | Dura Substitute | 第 2 类 | 21 CFR 882.5910 | 43 |
| GXR | Cover, Burr Hole | 第 2 类 | 21 CFR 882.5250 | 29 |
| GXS | Monitor, Alpha | 第 2 类 | 21 CFR 882.1610 | |
| GXT | Monitor, Lesion Temperature | 第 2 类 | 21 CFR 882.5500 | |
| GXW | Echoencephalograph | 第 2 类 | 21 CFR 882.1240 | 7 |
| GXX | Block, Test, Ultrasonic Scanner Calibration | 第 1 类 | 21 CFR 882.1925 | 3 |
| GXY | Electrode, Cutaneous | 第 2 类 | 21 CFR 882.1320 | 440 |
| GXZ | Electrode, Needle | 第 2 类 | 21 CFR 882.1350 | 53 |
| GYA | Tester, Electrode/Lead, Electroencephalograph | 第 1 类 | 21 CFR 882.1410 | 5 |
| GYB | Media, Electroconductive | 第 2 类 | 21 CFR 882.1275 | 69 |
| GYC | Electrode, Cortical | 第 2 类 | 21 CFR 882.1310 | 32 |
| GYD | Transducer, Tremor | 第 2 类 | 21 CFR 882.1950 | 15 |
| GYE | Encephalogram Telemetry System | 第 2 类 | 21 CFR 882.1855 | 20 |
| GYK | Instrument, Shunt System Implantation | 第 1 类 | 21 CFR 882.4545 | 13 |
| GYZ | Stimulator, Intracerebral/Subcortical, Implanted | 第 3 类 | 21 CFR 882.5840 | |
| GZA | Implanted Cerebellar Stimulator | 第 3 类 | 21 CFR 882.5820 | |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | 第 2 类 | 21 CFR 882.5880 | 139 |
| GZC | Stimulator, Neuromuscular, Implanted | 第 3 类 | 21 CFR 882.5860 | |
| GZD | Stimulator, Spinal-Cord, Implanted, For Bladder Evacuation | 第 3 类 | 21 CFR 882.5850 | |
| GZE | Implanted Diaphragmatic/Phrenic Nerve Stimulator | 第 3 类 | 21 CFR 882.5830 | |
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) | 第 2 类 | 21 CFR 882.5870 | 25 |
| GZI | Stimulator, Neuromuscular, External Functional | 第 2 类 | 21 CFR 882.5810 | 61 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 第 2 类 | 21 CFR 882.5890 | 606 |
| GZK | Electrode, Nasopharyngeal | 第 2 类 | 21 CFR 882.1340 | 2 |
| GZL | Electrode, Depth | 第 2 类 | 21 CFR 882.1330 | 58 |
| GZM | Analyzer, Rigidity | 第 2 类 | 21 CFR 882.1020 | |
| GZN | Rheoencephalograph | 第 3 类 | 21 CFR 882.1825 | |
| GZO | Device, Galvanic Skin Response Measurement | 第 2 类 | 21 CFR 882.1540 | 26 |
| GZP | Stimulator, Mechanical, Evoked Response | 第 2 类 | 21 CFR 882.1880 | 2 |
| GZQ | Instrument, Dowel Cutting | 第 2 类 | 21 CFR 882.4275 | 1 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | 第 2 类 | 21 CFR 882.4800 | 43 |
| GZX | Instrument, Microsurgical | 第 1 类 | 21 CFR 882.4525 | 13 |
| HAD | Rongeur, Powered | 第 2 类 | 21 CFR 882.4845 | 3 |
| HAE | Rongeur, Manual | 第 2 类 | 21 CFR 882.4840 | 36 |
| HAO | Instrument, Surgical, Non-Powered | 第 1 类 | 21 CFR 882.4535 | 34 |
| HAS | Needle, Neurosurgical Suture | 第 1 类 | 21 CFR 882.4650 | |
| HAW | Neurological Stereotaxic Instrument | 第 2 类 | 21 CFR 882.4560 | 424 |
| HAX | Tong, Skull For Traction | 第 2 类 | 21 CFR 882.5960 | 20 |
| HBA | Neurosurgical Paddie | 第 2 类 | 21 CFR 882.4700 | 24 |
| HBB | Motor, Drill, Pneumatic | 第 2 类 | 21 CFR 882.4370 | 27 |
| HBC | Motor, Drill, Electric | 第 2 类 | 21 CFR 882.4360 | 26 |
| HBD | Handpiece (Brace), Drill | 第 1 类 | 21 CFR 882.4325 | |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 第 2 类 | 21 CFR 882.4310 | 65 |
| HBF | Drills, Burrs, Trephines & Accessories (Compound, Powered) | 第 2 类 | 21 CFR 882.4305 | 18 |
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | 第 2 类 | 21 CFR 882.4300 | 17 |
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | 第 2 类 | 21 CFR 882.4460 | 50 |
| HBM | Headrest, Neurosurgical | 第 1 类 | 21 CFR 882.4440 | 3 |
| HBN | Chair, Neurosurgical | 第 1 类 | 21 CFR 882.4125 | 4 |
| HBO | Clip, Scalp | 第 2 类 | 21 CFR 882.4150 | 11 |
| HBP | Clip, Implanted Malleable | 第 2 类 | 21 CFR 882.5225 | |
| HBQ | Instrument, Clip Removal | 第 1 类 | 21 CFR 882.4200 | |
| HBR | Rack, Clip | 第 1 类 | 21 CFR 882.4215 | 1 |
| HBS | Instrument, Clip Forming/Cutting | 第 1 类 | 21 CFR 882.4190 | |
| HBW | Fastener, Plate, Cranioplasty | 第 2 类 | 21 CFR 882.5360 | 7 |
| HBX | Instrument, Cranioplasty Material Forming | 第 1 类 | 21 CFR 882.4500 | |
| HBZ | Catheter, Intravascular Occluding | 第 3 类 | 21 CFR 882.5150 | |
| HCA | Catheter, Ventricular | 第 2 类 | 21 CFR 882.4100 | 10 |
| HCB | Device, Aversive Conditioning | 第 2 类 | 21 CFR 882.5235 | 6 |
| HCC | Device, Biofeedback | 第 2 类 | 21 CFR 882.5050 | 172 |
| HCD | Cannula, Ventricular | 第 1 类 | 21 CFR 882.4060 | 3 |
| HCE | Clamp, Carotid Artery | 第 2 类 | 21 CFR 882.5175 | 2 |
| HCG | Device, Neurovascular Embolization | 第 2 类 | 21 CFR 882.5950 | 187 |
| HCH | Clip, Aneurysm | 第 2 类 | 21 CFR 882.5200 | 36 |
| HCI | Applier, Aneurysm Clip | 第 2 类 | 21 CFR 882.4175 | 14 |
| HCJ | Device, Skin Potential Measurement | 第 2 类 | 21 CFR 882.1560 | 2 |
| HCS | Device, Temperature Measurement, Direct Contact, Powered | 第 2 类 | 21 CFR 882.1570 | 8 |
| JXE | Device, Nerve Conduction Velocity Measurement | 第 2 类 | 21 CFR 882.1550 | 27 |
| JXF | Plethysmograph, Ocular | 第 3 类 | 21 CFR 882.1790 | |
| JXG | Shunt, Central Nervous System And Components | 第 2 类 | 21 CFR 882.5550 | 259 |
| JXH | Methyl Methacrylate For Aneurysmorrhaphy | 第 2 类 | 21 CFR 882.5030 | 3 |
| JXI | Cuff, Nerve | 第 2 类 | 21 CFR 882.5275 | 40 |
| JXK | Cranial Electrotherapy Stimulator To Treat Depression | 第 3 类 | 21 CFR 882.5800 | |
| JXL | Block, Bite | 第 2 类 | 21 CFR 882.5070 | 28 |
| LEL | Device, Sleep Assessment | 第 2 类 | 21 CFR 882.5050 | 19 |
| LEM | Human Lyophilized Dura Mater | 第 2 类 | 21 CFR 882.5975 | 2 |
| LHG | Electrode, Spinal Epidural | 第 2 类 | 21 CFR 882.5880 | 1 |
| LIH | Interferential Current Therapy | 第 2 类 | 21 CFR 882.5890 | 73 |
| LKG | Port & Catheter, Implanted, Subcutaneous, Intraventricular | 第 2 类 | 21 CFR 882.5550 | 8 |
| LLN | Device, Vibration Threshold Measurement | 第 1 类 | 21 CFR 882.1200 | 13 |
| LQW | Test, Temperature Discrimination | 第 1 类 | 21 CFR 882.1200 | 3 |
| MVA | Orthosis, Cranial | 第 2 类 | 21 CFR 882.5970 | 43 |
| MYU | Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty | 第 2 类 | 21 CFR 882.5300 | 6 |
| MZQ | Balloon, Detachable, For Neurovascular Occlusion | 第 2 类 | 21 CFR 882.5950 | 2 |
| NCG | Neuropsychiatric Interpretative Electroencephalograph Assessment Aid | 第 2 类 | 21 CFR 882.1440 | 3 |
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | 第 2 类 | 21 CFR 882.5890 | 79 |
| NHC | Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents) | 第 2 类 | 21 CFR 882.4100 | 3 |
| NHI | Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief | 第 2 类 | 21 CFR 882.5890 | 13 |
| NLN | Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed | 第 2 类 | 21 CFR 882.4310 | 1 |
| NLO | Drills, Burrs, Trephines And Accessories (Manual), Reprocessed | 第 2 类 | 21 CFR 882.4300 | |
| NLP | Drills, Burrs, Trephines, And Accessories (Powered Compound), Reproces | 第 2 类 | 21 CFR 882.4305 | |
| NMN | Instrument, Clip, Forming/Cutting, Reprocessed | 第 1 类 | 21 CFR 882.4190 | |
| NTU | Evoked Potential Stimulator, Thermal | 第 2 类 | 21 CFR 882.1870 | 3 |
| NUF | Catheter, Neurovasculature, Occluding Balloon | 第 3 类 | 21 CFR 882.5150 | |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 第 2 类 | 21 CFR 882.5890 | 229 |
| NYN | Stimulator, Electrical, Transcutaneous, For Arthritis | 第 2 类 | 21 CFR 882.5890 | 8 |
| NYW | Stimulator, Nerve, Electrical, Transcutaneous, With Limited Output, Fo | 第 2 类 | 21 CFR 882.5890 | |
| NYX | Stimulator, Electrical, Transcutaneous, With Limited Output, For Aesth | 第 2 类 | 21 CFR 882.5890 | |
| OAN | Orthosis, Cranial, Laser Scan | 第 2 类 | 21 CFR 882.5970 | 23 |
| OBP | Transcranial Magnetic Stimulator | 第 2 类 | 21 CFR 882.5805 | 68 |
| OBV | Eating Disorder Conditioning Tool | 第 2 类 | 21 CFR 882.5060 | 1 |
| OCF | Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthrit | 第 2 类 | 21 CFR 882.5890 | 1 |
| OEW | Tracking, Soft Tissue, Intraoperative | 第 2 类 | 21 CFR 882.4560 | 4 |
| OJG | Neurological Tray | 第 1 类 | 21 CFR 882.4525 | |
| OJP | Orthopedic Computer Controlled Surgical System | 第 2 类 | 21 CFR 882.4560 | 4 |
| OKP | Transcranial Magnetic Stimulator For The Treatment Of Migraine Headach | 第 2 类 | 21 CFR 882.5808 | 6 |
| OLO | Orthopedic Stereotaxic Instrument | 第 2 类 | 21 CFR 882.4560 | 440 |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | 第 2 类 | 21 CFR 882.1400 | 56 |
| OLU | Normalizing Quantitative Electroencephalograph Software | 第 2 类 | 21 CFR 882.1400 | 13 |
| OLV | Standard Polysomnograph With Electroencephalograph | 第 2 类 | 21 CFR 882.1400 | 65 |
| OLW | Index-Generating Electroencephalograph Software | 第 2 类 | 21 CFR 882.1400 | 40 |
| OLX | Source Localization Software For Electroencephalograph Or Magnetoencep | 第 2 类 | 21 CFR 882.1400 | 25 |
| OLY | Magnetoencephalograph | 第 2 类 | 21 CFR 882.1400 | 6 |
| OLZ | Automatic Event Detection Software For Polysomnograph With Electroence | 第 2 类 | 21 CFR 882.1400 | 37 |
| OMA | Amplitude-Integrated Electroencephalograph | 第 2 类 | 21 CFR 882.1400 | 16 |
| OMB | Automatic Event Detection Software For Full-Montage Electroencephalogr | 第 2 类 | 21 CFR 882.1400 | 42 |
| OMC | Reduced- Montage Standard Electroencephalograph | 第 2 类 | 21 CFR 882.1400 | 29 |
| ONA | Computer Assisted Hair Harvesting System | 第 2 类 | 21 CFR 882.4560 | 4 |
| ONN | Intraoperative Orthopedic Joint Assessment Aid | 第 2 类 | 21 CFR 882.4560 | 18 |
| ORR | Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri | 第 2 类 | 21 CFR 882.4560 | 4 |
| ORT | Burst Suppression Detection Software For Electroencephalograph | 第 2 类 | 21 CFR 882.1400 | 1 |
| OSE | Patient Specific Manual Navigation System | 第 2 类 | 21 CFR 882.4560 | |
| OSF | Patient Specific Manual Orthopedic Stereotaxic System | 第 2 类 | 21 CFR 882.4560 | 3 |
| OSG | Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch | 第 2 类 | 21 CFR 882.5894 | 2 |
| PAV | Catheter, Neuro-Vasculature, Occluding Balloon | 第 F 类 | 21 CFR 882.5150 | |
| PBJ | Cranial Distraction System | 第 2 类 | 21 CFR 882.5330 | 6 |
| PCB | External Cerebrospinal Fluid (Csf) Diversion | 第 2 类 | 21 CFR 882.5560 | 2 |
| PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | 第 2 类 | 21 CFR 882.5891 | 18 |
| PGW | Ear, Nose, And Throat Stereotaxic Instrument | 第 2 类 | 21 CFR 882.4560 | 37 |
| PIW | Brain Injury Adjunctive Interpretive Electroencephalograph Assessment | 第 2 类 | 21 CFR 882.1450 | 9 |
| PIY | Stainless Steel Instrument, Shunt System Implantation | 第 1 类 | 21 CFR 882.4545 | |
| PJM | Filler, Bone Void, Alterable Compound For Cranioplasty | 第 2 类 | 21 CFR 882.5320 | |
| PJN | Filler, Bone Void, Non-Alterable Compound For Cranioplasty | 第 2 类 | 21 CFR 882.5330 | 2 |
| PKQ | Computerized Cognitive Assessment Aid | 第 2 类 | 21 CFR 882.1470 | 3 |
| PKR | Non-Invasive Vagus Nerve Stimulator - Headache | 第 2 类 | 21 CFR 882.5892 | 9 |
| PLU | Thermal System For Insomnia | 第 2 类 | 21 CFR 882.5700 | 1 |
| PNA | Evoked Photon Image Capture Device | 第 1 类 | 21 CFR 882.1561 | 1 |
| POL | Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke | 第 2 类 | 21 CFR 882.5600 | 18 |
| POM | Computerized Cognitive Assessment Aid For Concussion | 第 2 类 | 21 CFR 882.1471 | 8 |
| POP | Cranial Motion Measurement Device | 第 2 类 | 21 CFR 882.1630 | 2 |
| POS | Physiological Signal Based Seizure Monitoring System | 第 2 类 | 21 CFR 882.1580 | 10 |
| PPT | Cranial Surgical Planning And Instrument Guides | 第 2 类 | 21 CFR 882.4310 | 4 |
| PSP | Intracranial Pressure & Temperature Monitoring Kit | 第 2 类 | 21 CFR 882.1620 | |
| PTB | Ataxiagraph With Interpretive Software | 第 1 类 | 21 CFR 882.1030 | |
| PTY | Computerized Cognitive Assessment Aid, Exempt | 第 2 类 | 21 CFR 882.1470 | |
| PUU | Temporary Coil Embolization Assist Device | 第 2 类 | 21 CFR 882.5955 | 1 |
| PVL | Endoscopic Shunt Placement Kit | 第 2 类 | 21 CFR 882.5550 | |
| PVM | Endoscopic Ventricular Catheter Placement Kit | 第 2 类 | 21 CFR 882.4100 | |
| PVO | Lumbar Drainage Catheter Kit | 第 2 类 | 21 CFR 882.5550 | |
| PVP | Neurological Test Kit | 第 1 类 | 21 CFR 882.1750 | |
| PWE | Computerized Behavioral Therapy Device For Substance Use Disorders | 第 2 类 | 21 CFR 882.5801 | 2 |
| PZR | Percutaneous Nerve Stimulator For Opioid Withdrawal | 第 2 类 | 21 CFR 882.5896 | 8 |
| QAK | Non-Invasive Vagus Nerve Stimulator For Migraine Headache | 第 2 类 | 21 CFR 882.5892 | |
| QAR | Thermal Vestibular Stimulator For Headache | 第 2 类 | 21 CFR 882.5893 | 1 |
| QBC | External Upper Limb Tremor Stimulator | 第 2 类 | 21 CFR 882.5897 | 9 |
| QCF | Electrical Tongue Stimulator To Treat Motor Deficits | 第 2 类 | 21 CFR 882.5889 | 2 |
| QCI | Transcranial Magnetic Stimulation System For Obsessive-Compulsive Diso | 第 2 类 | 21 CFR 882.5802 | 9 |
| QEA | Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid | 第 2 类 | 21 CFR 882.1455 | 7 |
| QEO | Light Attenuation Lenses For Migraine-Associated Light Sensitivity | 第 1 类 | 21 CFR 882.5811 | 1 |
| QFD | Tens For Sinus Pain | 第 2 类 | 21 CFR 882.5890 | |
| QFF | Electromechanical Arm For A Transcranial Magnetic Stimulation System | 第 2 类 | 21 CFR 882.5805 | 2 |
| QFX | Diagnostic Neurosurgical Microscope Filter | 第 2 类 | 21 CFR 882.4950 | 5 |
| QGH | Electroconvulsive Therapy Device For Catatonia, Major Depressive Disor | 第 2 类 | 21 CFR 882.5940 | 9 |
| QGL | Transcutaneous Nerve Stimulator For Adhd | 第 2 类 | 21 CFR 882.5898 | 5 |
| QGT | Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Mig | 第 2 类 | 21 CFR 882.5899 | 7 |
| QJQ | Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety | 第 2 类 | 21 CFR 882.5800 | 19 |
| QLV | Field Generator Positioning Device | 第 1 类 | 21 CFR 882.4565 | |
| QMD | Transcranial Magnetic Stimulation System For Smoking Cessation | 第 2 类 | 21 CFR 882.5802 | 2 |
| QMZ | Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Con | 第 2 类 | 21 CFR 882.5705 | 1 |
| QNX | External Compression Device For Internal Jugular Vein Compression | 第 2 类 | 21 CFR 890.3050 | 1 |
| QOL | Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser | 第 2 类 | 21 CFR 890.5420 | 1 |
| QPF | Pediatric Autism Spectrum Disorder Diagnosis Aid | 第 2 类 | 21 CFR 882.1491 | 6 |