| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| BYS | Oxygenator, Long Term Support Greater Than 6 Hours | 第 2 类 | 21 CFR 870.4100 | 3 |
| DPS | Electrocardiograph | 第 2 类 | 21 CFR 870.2340 | 576 |
| DPT | Probe, Blood-Flow, Extravascular | 第 2 类 | 21 CFR 870.2120 | 48 |
| DPW | Flowmeter, Blood, Cardiovascular | 第 2 类 | 21 CFR 870.2100 | 138 |
| DPZ | Oximeter, Ear | 第 2 类 | 21 CFR 870.2710 | 11 |
| DQA | Oximeter | 第 2 类 | 21 CFR 870.2700 | 726 |
| DQB | Phlebograph, Impedance | 第 2 类 | 21 CFR 870.2750 | 3 |
| DQC | Phonocardiograph | 第 1 类 | 21 CFR 870.2390 | 18 |
| DQD | Stethoscope, Electronic | 第 2 类 | 21 CFR 870.1875 | 156 |
| DQE | Catheter, Oximeter, Fiber-Optic | 第 2 类 | 21 CFR 870.1230 | 19 |
| DQF | Actuator, Syringe, Injector Type | 第 2 类 | 21 CFR 870.1670 | 3 |
| DQG | Microsphere, Trace | 第 3 类 | 21 CFR 870.1360 | |
| DQH | Cardiograph, Apex (Vibrocardiograph) | 第 2 类 | 21 CFR 870.2310 | 1 |
| DQI | Withdrawal/Infusion Pump | 第 2 类 | 21 CFR 870.1800 | 9 |
| DQK | Computer, Diagnostic, Programmable | 第 2 类 | 21 CFR 870.1425 | 437 |
| DQO | Catheter, Intravascular, Diagnostic | 第 2 类 | 21 CFR 870.1200 | 501 |
| DQP | Kit, Balloon Repair, Catheter | 第 3 类 | 21 CFR 870.1350 | |
| DQR | Cannula, Catheter | 第 2 类 | 21 CFR 870.1300 | 25 |
| DQT | Occluder, Catheter Tip | 第 2 类 | 21 CFR 870.1370 | 12 |
| DQX | Wire, Guide, Catheter | 第 2 类 | 21 CFR 870.1330 | 766 |
| DQY | Catheter, Percutaneous | 第 2 类 | 21 CFR 870.1250 | 895 |
| DRA | Catheter, Steerable | 第 2 类 | 21 CFR 870.1280 | 42 |
| DRB | Stylet, Catheter | 第 2 类 | 21 CFR 870.1380 | 28 |
| DRC | Trocar | 第 2 类 | 21 CFR 870.1390 | 51 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 第 2 类 | 21 CFR 870.1310 | 105 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 第 2 类 | 21 CFR 870.1220 | 185 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 第 2 类 | 21 CFR 870.2910 | 192 |
| DRI | Monitor, Line Isolation | 第 1 类 | 21 CFR 870.2620 | 4 |
| DRJ | System, Signal Isolation | 第 1 类 | 21 CFR 870.2600 | 4 |
| DRK | Dc-Defibrillator, High Energy, (Including Paddles) | 第 3 类 | 21 CFR 870.5300 | 1 |
| DRL | Tester, Defibrillator | 第 2 类 | 21 CFR 870.5325 | 19 |
| DRM | Compressor, Cardiac, External | 第 2 类 | 21 CFR 870.5200 | 45 |
| DRN | Device, Counter-Pulsating, External | 第 2 类 | 21 CFR 870.5225 | 34 |
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | 第 2 类 | 21 CFR 870.5550 | 84 |
| DRP | Tourniquet, Automatic Rotating | 第 2 类 | 21 CFR 870.5925 | |
| DRQ | Amplifier And Signal Conditioner, Transducer Signal | 第 2 类 | 21 CFR 870.2060 | 27 |
| DRR | Amplifier And Signal Conditioner, Biopotential | 第 2 类 | 21 CFR 870.2050 | 24 |
| DRS | Transducer, Blood-Pressure, Extravascular | 第 2 类 | 21 CFR 870.2850 | 148 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 第 2 类 | 21 CFR 870.2300 | 339 |
| DRW | Adaptor, Lead Switching, Electrocardiograph | 第 2 类 | 21 CFR 870.2350 | 8 |
| DRX | Electrode, Electrocardiograph | 第 2 类 | 21 CFR 870.2360 | 329 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 第 2 类 | 21 CFR 870.4330 | 47 |
| DRZ | Oscillometer | 第 2 类 | 21 CFR 870.2675 | |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 第 2 类 | 21 CFR 870.2900 | 105 |
| DSB | Plethysmograph, Impedance | 第 2 类 | 21 CFR 870.2770 | 115 |
| DSF | Recorder, Paper Chart | 第 1 类 | 21 CFR 870.2810 | 87 |
| DSH | Recorder, Magnetic Tape, Medical | 第 2 类 | 21 CFR 870.2800 | 195 |
| DSI | Detector And Alarm, Arrhythmia | 第 2 类 | 21 CFR 870.1025 | 398 |
| DSJ | Alarm, Blood-Pressure | 第 2 类 | 21 CFR 870.1100 | 6 |
| DSK | Computer, Blood-Pressure | 第 2 类 | 21 CFR 870.1110 | 77 |
| DSM | Alarm, Leakage Current, Portable | 第 1 类 | 21 CFR 870.2640 | 1 |
| DSP | System, Balloon, Intra-Aortic And Control | 第 2 类 | 21 CFR 870.3535 | 162 |
| DSR | Stimulator, Carotid Sinus Nerve | 第 3 类 | 21 CFR 870.3850 | |
| DSS | Clip, Vascular | 第 2 类 | 21 CFR 870.3250 | 8 |
| DST | Clip, Vena-Cava | 第 2 类 | 21 CFR 870.3260 | 1 |
| DSW | Bag, Polymeric Mesh, Pacemaker | 第 1 类 | 21 CFR 870.3650 | |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 第 2 类 | 21 CFR 870.3450 | 188 |
| DSZ | Pacemaker Battery | 第 3 类 | 21 CFR 870.3610 | |
| DTA | Tester, Pacemaker Electrode Function | 第 2 类 | 21 CFR 870.3720 | 10 |
| DTB | Permanent Pacemaker Electrode | 第 3 类 | 21 CFR 870.3680 | 487 |
| DTC | Analyzer, Pacemaker Generator Function | 第 2 类 | 21 CFR 870.3630 | 30 |
| DTD | Pacemaker Lead Adaptor | 第 2 类 | 21 CFR 870.3620 | 103 |
| DTE | Pulse-Generator, Pacemaker, External | 第 2 类 | 21 CFR 870.3600 | 65 |
| DTF | Tools, Pacemaker Service | 第 1 类 | 21 CFR 870.3730 | 2 |
| DTG | Magnet, Test, Pacemaker | 第 1 类 | 21 CFR 870.3690 | 5 |
| DTI | Sizer, Heart-Valve, Prosthesis | 第 1 类 | 21 CFR 870.3945 | 7 |
| DTJ | Holder, Heart-Valve, Prosthesis | 第 1 类 | 21 CFR 870.3935 | 12 |
| DTK | Filter, Intravascular, Cardiovascular | 第 2 类 | 21 CFR 870.3375 | 83 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 第 2 类 | 21 CFR 870.4290 | 137 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 第 2 类 | 21 CFR 870.4260 | 96 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 第 2 类 | 21 CFR 870.4400 | 169 |
| DTP | Defoamer, Cardiopulmonary Bypass | 第 2 类 | 21 CFR 870.4230 | 34 |
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 第 2 类 | 21 CFR 870.4220 | 52 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 第 2 类 | 21 CFR 870.4240 | 91 |
| DTS | Sucker, Cardiotomy Return, Cardiopulmonary Bypass | 第 2 类 | 21 CFR 870.4420 | 9 |
| DTW | Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass | 第 2 类 | 21 CFR 870.4340 | 17 |
| DTX | Gas Control Unit, Cardiopulmonary Bypass | 第 2 类 | 21 CFR 870.4300 | 10 |
| DTY | Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass | 第 2 类 | 21 CFR 870.4410 | 8 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 第 2 类 | 21 CFR 870.4350 | 254 |
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | 第 2 类 | 21 CFR 870.4380 | 37 |
| DWB | Pump, Blood, Cardiopulmonary Bypass, Roller Type | 第 2 类 | 21 CFR 870.4370 | 21 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | 第 2 类 | 21 CFR 870.4250 | 30 |
| DWD | Suction Control, Intracardiac, Cardiopulmonary Bypass | 第 2 类 | 21 CFR 870.4430 | 15 |
| DWE | Tubing, Pump, Cardiopulmonary Bypass | 第 2 类 | 21 CFR 870.4390 | 21 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 第 2 类 | 21 CFR 870.4210 | 401 |
| DWJ | System, Thermal Regulating | 第 2 类 | 21 CFR 870.5900 | 161 |
| DWM | Apparatus, Suction, Patient Care | 第 2 类 | 21 CFR 870.5050 | 19 |
| DWP | Dilator, Vessel, Surgical | 第 2 类 | 21 CFR 870.4475 | 20 |
| DWQ | Stripper, Vein, External | 第 2 类 | 21 CFR 870.4885 | 8 |
| DWS | Instruments, Surgical, Cardiovascular | 第 1 类 | 21 CFR 870.4500 | 71 |
| DWX | Stripper, Artery, Intraluminal | 第 2 类 | 21 CFR 870.4875 | 14 |
| DWZ | Device, Biopsy, Endomyocardial | 第 2 类 | 21 CFR 870.4075 | 23 |
| DXC | Clamp, Vascular | 第 2 类 | 21 CFR 870.4450 | 205 |
| DXE | Catheter, Embolectomy | 第 2 类 | 21 CFR 870.5150 | 74 |
| DXF | Catheter, Septostomy | 第 2 类 | 21 CFR 870.5175 | 21 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 第 2 类 | 21 CFR 870.1435 | 177 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 第 2 类 | 21 CFR 870.2920 | 297 |
| DXJ | Display, Cathode-Ray Tube, Medical | 第 2 类 | 21 CFR 870.2450 | 78 |
| DXK | Echocardiograph | 第 2 类 | 21 CFR 870.2330 | 78 |
| DXL | Injector, Indicator | 第 2 类 | 21 CFR 870.1660 | 3 |
| DXM | Densitometer | 第 2 类 | 21 CFR 870.1450 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 第 2 类 | 21 CFR 870.1130 | 1222 |
| DXO | Transducer, Pressure, Catheter Tip | 第 2 类 | 21 CFR 870.2870 | 64 |
| DXP | Transducer, Vessel Occlusion | 第 2 类 | 21 CFR 870.2890 | 2 |
| DXQ | Blood Pressure Cuff | 第 2 类 | 21 CFR 870.1120 | 199 |
| DXR | Ballistocardiograph | 第 2 类 | 21 CFR 870.2320 | 5 |
| DXS | Gauge, Pressure, Coronary, Cardiopulmonary Bypass | 第 2 类 | 21 CFR 870.4310 | 13 |
| DXT | Injector And Syringe, Angiographic | 第 2 类 | 21 CFR 870.1650 | 210 |
| DXW | System, Phonocatheter, Intracavitary | 第 2 类 | 21 CFR 870.1270 | 5 |
| DXX | System, Catheter Control, Steerable | 第 2 类 | 21 CFR 870.1290 | 34 |
| DXY | Implantable Pacemaker Pulse-Generator | 第 3 类 | 21 CFR 870.3610 | 461 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 第 2 类 | 21 CFR 870.3470 | 90 |
| DYB | Introducer, Catheter | 第 2 类 | 21 CFR 870.1340 | 706 |
| DYC | Vectorcardiograph | 第 2 类 | 21 CFR 870.2400 | 4 |
| DYE | Replacement Heart-Valve | 第 3 类 | 21 CFR 870.3925 | |
| DYF | Prosthesis, Vascular Graft, Of Less Then 6mm Diameter | 第 2 类 | 21 CFR 870.3450 | 21 |
| DYG | Catheter, Flow Directed | 第 2 类 | 21 CFR 870.1240 | 99 |
| IZQ | Injector, Contrast Medium, Automatic | 第 2 类 | 21 CFR 870.1650 | 23 |
| JOD | Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass | 第 2 类 | 21 CFR 870.4270 | 12 |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 第 2 类 | 21 CFR 870.2780 | 53 |
| JON | Transducer, Apex Cardiographic | 第 2 类 | 21 CFR 870.2840 | |
| JOO | Transducer, Heart Sound | 第 2 类 | 21 CFR 870.2860 | |
| JOP | Transducer, Ultrasonic | 第 2 类 | 21 CFR 870.2880 | 72 |
| JOQ | Generator, Pulse, Pacemaker, External Programmable (For Electrophysiol | 第 2 类 | 21 CFR 870.1750 | 18 |
| JOR | Generator, Pulsatile Flow, Cardiopulmonary Bypass | 第 3 类 | 21 CFR 870.4320 | |
| JOW | Sleeve, Limb, Compressible | 第 2 类 | 21 CFR 870.5800 | 352 |
| KFJ | Materials, Repair Or Replacement, Pacemaker | 第 3 类 | 21 CFR 870.3710 | 3 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 第 2 类 | 21 CFR 870.4360 | 84 |
| KRA | Catheter, Continuous Flush | 第 2 类 | 21 CFR 870.1210 | 175 |
| KRB | Probe, Thermodilution | 第 2 类 | 21 CFR 870.1915 | 37 |
| KRC | Tester, Electrode, Surface, Electrocardiographic | 第 2 类 | 21 CFR 870.2370 | 11 |
| KRD | Device, Vascular, For Promoting Embolization | 第 2 类 | 21 CFR 870.3300 | 132 |
| KRE | Analyzer, Pacemaker Generator Function, Indirect | 第 2 类 | 21 CFR 870.3640 | 13 |
| KRF | Charger, Pacemaker | 第 1 类 | 21 CFR 870.3670 | |
| KRG | Programmer, Pacemaker | 第 3 类 | 21 CFR 870.3700 | 25 |
| KRH | Ring, Annuloplasty | 第 2 类 | 21 CFR 870.3800 | 75 |
| KRI | Accessory Equipment, Cardiopulmonary Bypass | 第 1 类 | 21 CFR 870.4200 | 42 |
| KRJ | Filter, Prebypass, Cardiopulmonary Bypass | 第 2 类 | 21 CFR 870.4280 | 24 |
| KRK | Manometer, Blood-Pressure, Venous | 第 2 类 | 21 CFR 870.1140 | 9 |
| KRL | Detector, Bubble, Cardiopulmonary Bypass | 第 2 类 | 21 CFR 870.4205 | 14 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 第 2 类 | 21 CFR 870.5300 | 166 |
| LDE | Stethoscope, Manual | 第 1 类 | 21 CFR 870.1875 | 28 |
| LDF | Electrode, Pacemaker, Temporary | 第 2 类 | 21 CFR 870.3680 | 130 |
| LHX | Trousers, Anti-Shock | 第 2 类 | 21 CFR 870.5800 | 4 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 第 2 类 | 21 CFR 870.1250 | 403 |
| LIX | Aid, Cardiopulmonary Resuscitation | 第 2 类 | 21 CFR 870.5210 | 17 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 第 2 类 | 21 CFR 870.5100 | 88 |
| LXN | Probe, Test, Heart-Valve | 第 1 类 | 21 CFR 870.4500 | 2 |
| MAB | Marker, Cardiopulmonary Bypass (Vein Marker) | 第 2 类 | 21 CFR 870.3450 | 3 |
| MAL | Graft, Vascular, Synthetic/Biologic Composite | 第 2 类 | 21 CFR 870.3450 | 6 |
| MAV | Syringe, Balloon Inflation | 第 2 类 | 21 CFR 870.1650 | 57 |
| MCW | Catheter, Peripheral, Atherectomy | 第 2 类 | 21 CFR 870.4875 | 146 |
| MFX | Vessel Guard Or Cover, To Facilitate Revision Surgeries | 第 2 类 | 21 CFR 870.3470 | 2 |
| MFY | Endothelial Cell Harvesting Kit | 第 2 类 | 21 CFR 870.4075 | 1 |
| MGZ | Valvulotome | 第 2 类 | 21 CFR 870.4885 | 27 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 第 2 类 | 21 CFR 870.1025 | 429 |
| MJJ | Cpb Check Valve, Retrograde Flow, In-Line | 第 2 类 | 21 CFR 870.4400 | 9 |
| MJN | Catheter, Intravascular Occluding, Temporary | 第 2 类 | 21 CFR 870.4450 | 90 |
| MKJ | Automated External Defibrillators (Non-Wearable) | 第 3 类 | 21 CFR 870.5310 | 228 |
| MLC | Monitor, St Segment | 第 2 类 | 21 CFR 870.2340 | 2 |
| MLD | Monitor, St Segment With Alarm | 第 2 类 | 21 CFR 870.1025 | 14 |
| MLN | Electrode, Electrocardiograph, Multi-Function | 第 2 类 | 21 CFR 870.2360 | |
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | 第 2 类 | 21 CFR 870.2800 | 32 |
| MMX | Device, Percutaneous Retrieval | 第 2 类 | 21 CFR 870.5150 | 32 |
| MNJ | Valve, Pressure Relief, Cardiopulmonary Bypass | 第 2 类 | 21 CFR 870.4400 | 2 |
| MNW | Analyzer, Body Composition | 第 2 类 | 21 CFR 870.2770 | 79 |
| MOF | Guide, Wire, Catheter, Neurovasculature | 第 2 类 | 21 CFR 870.1330 | 44 |
| MOP | Rotator, Prosthetic Heart Valve | 第 1 类 | 21 CFR 870.3935 | 4 |
| MPC | Atrial Defibrillator | 第 3 类 | 21 CFR 870.5300 | |
| MPD | Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator | 第 2 类 | 21 CFR 870.5300 | 3 |
| MPE | Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac P | 第 2 类 | 21 CFR 870.5550 | 1 |
| MSX | System, Network And Communication, Physiological Monitors | 第 2 类 | 21 CFR 870.2300 | 119 |
| MTD | Catheter, Intracardiac Mapping, High-Density Array | 第 2 类 | 21 CFR 870.1220 | 34 |
| MUD | Oximeter, Tissue Saturation | 第 2 类 | 21 CFR 870.2700 | 74 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarm | 第 2 类 | 21 CFR 870.2300 | 308 |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 第 2 类 | 21 CFR 870.2800 | 62 |
| MWS | Stabilizer, Heart | 第 1 类 | 21 CFR 870.4500 | 4 |
| MXC | Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) | 第 2 类 | 21 CFR 870.2800 | 23 |
| MXD | Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) | 第 2 类 | 21 CFR 870.1025 | 34 |
| MZY | Graft, Vascular, Stainless Steel Tunneler | 第 2 类 | 21 CFR 870.3450 | |
| NAJ | Agents, Embolic, For Treatment Of Uterine Fibroids | 第 2 类 | 21 CFR 870.3300 | 8 |
| NCX | System, Hypothermia, Intravenous, Cooling | 第 2 类 | 21 CFR 870.5900 | 26 |
| NDQ | System, Catheter Or Guidewire, Steerable (Magnetic) | 第 2 类 | 21 CFR 870.1290 | 2 |
| NFA | Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection | 第 2 类 | 21 CFR 870.1250 | 22 |
| NHW | Electrode, Pacing And Cardioversion, Temporary, Epicardial | 第 2 类 | 21 CFR 870.3680 | 2 |
| NKO | System, Balloon, Intra-Aortic And Control, Reprocessed | 第 3 类 | 21 CFR 870.3535 | |
| NKP | Injector, Contrast Medium, Automatic, Reprocessed | 第 2 类 | 21 CFR 870.1650 | |
| NKQ | Guidewire, Catheter, Reprocessed | 第 2 类 | 21 CFR 870.1330 | |
| NKR | System, Catheter Control, Reprocessed | 第 2 类 | 21 CFR 870.1290 | |
| NKS | Catheter, Steerable, Reprocessed | 第 2 类 | 21 CFR 870.1280 | |
| NKT | Injector And Syringe, Angiographic, Reprocessed | 第 2 类 | 21 CFR 870.1650 | |
| NKU | Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed | 第 2 类 | 21 CFR 870.1650 | 1 |
| NKW | Actuator, Syringe, For Injector, Reprocessed | 第 2 类 | 21 CFR 870.1670 | |
| NLF | Oximeter, Reprocessed | 第 2 类 | 21 CFR 870.2700 | 27 |
| NLG | Catheter, Intracardiac Mapping, High-Density, Reprocessed | 第 2 类 | 21 CFR 870.1220 | 3 |
| NLH | Catheter, Recording, Electrode, Reprocessed | 第 2 类 | 21 CFR 870.1220 | 70 |
| NLI | Catheter, Angiography, Reprocessed | 第 2 类 | 21 CFR 870.1200 | 1 |
| NLJ | Stripper, Vein, External, Reprocessed | 第 2 类 | 21 CFR 870.4885 | |
| NMB | Catheter, Oximeter, Fiber Optic, Reprocessed | 第 2 类 | 21 CFR 870.1230 | |
| NMD | Oximeter, Tissue Saturation, Reprocessed | 第 2 类 | 21 CFR 870.2700 | 2 |