| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| MLY | Vapocoolant Device | 第 U 类 | | 24 |
| MMA | Oximeter, Fetal Pulse | 第 3 类 | | |
| MMY | Lipoprotein, Low Density, Removal | 第 3 类 | | |
| MNB | Device, Thermal Ablation, Endometrial | 第 3 类 | | |
| MNM | Reader, Cervical Cytology Slide, Automated | 第 3 类 | | |
| MNO | System, Laser, Transmyocardial Revascularization | 第 3 类 | | |
| MNQ | Stimulator, Hypoglossal Nerve, Implanted, Apnea | 第 3 类 | | |
| MOA | Analyzer, Diagnostic, Fiber Optic (Colon) | 第 3 类 | | |
| MOM | System, Hemodynamic, Implantable | 第 3 类 | | |
| MOT | Irradiator, Blood To Prevent Graft Versus Host Disease | 第 U 类 | | 16 |
| MOU | Intravascular Radiation Delivery System | 第 3 类 | | |
| MOZ | Acid, Hyaluronic, Intraarticular | 第 3 类 | | |
| MPK | Semi-Constrained Metal/Polymer Finger Joint Prosthesis | 第 F 类 | | |
| MPR | Stent, Bladder, Fetal | 第 F 类 | | |
| MPV | Implant, Hearing, Active, Middle Ear, Partially Implanted | 第 3 类 | | |
| MPW | Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffol | 第 3 类 | | |
| MQC | Mouthguard, Prescription | 第 U 类 | | 71 |
| MQO | Prosthetic Disc Nucleus Device | 第 N 类 | | |
| MQT | Pump, Drug Administration, Closed Loop | 第 3 类 | | |
| MQZ | Prosthesis, Nail | 第 U 类 | | 4 |
| MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cement | 第 3 类 | | |
| MRD | Mammary Sizer | 第 U 类 | | 13 |
| MRE | Solution, Sodium Hyaluronate | 第 3 类 | | |
| MRJ | Ring, Endocapsular | 第 3 类 | | |
| MRK | System, Imaging, Fluorescence | 第 3 类 | | |
| MRM | Defibrillator, Implantable, Dual-Chamber | 第 3 类 | | |
| MRU | Implanted Subcortical Electrical Stimulator (Motor Disorders) | 第 F 类 | | |
| MRW | System, Facet Screw Spinal Device | 第 U 类 | | 78 |
| MSI | Solution, Cleaning / Lubricating, Artificial Eye | 第 3 类 | | 1 |
| MSK | Immunoassay For Blood Tacrolimus | 第 N 类 | | |
| MTA | Lens, Intraocular, Phakic | 第 3 类 | | |
| MTE | System, Pacing, Temporary, Acute, Internal Atrial Defibrillation | 第 3 类 | | |
| MTF | Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detect | 第 3 类 | | |
| MTG | Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish P | 第 3 类 | | |
| MTH | Tray, Leukocyte Typing | 第 N 类 | | |
| MTI | Kit, Cell Screening, Fetal | 第 N 类 | | |
| MTJ | Wax, Bone | 第 U 类 | | 42 |
| MTK | Kit, Sample Collection, Hiv | 第 3 类 | | |
| MTL | Monitor,Test,Hiv-1 | 第 3 类 | | |
| MTN | Test, Syphilis, Treponemal | 第 N 类 | | |
| MTO | Software, Management, Microplate Assay | 第 N 类 | | |
| MTP | Antibody To Htlv-1, Elisa | 第 3 类 | | |
| MTQ | Software, Blood Virus Applications | 第 N 类 | | |
| MTR | Progenitor Cell Enumeration | 第 2 类 | | |
| MTS | Vials, Challenge, Endotoxin | 第 N 类 | | |
| MUQ | Glue, Surgical, Arteries | 第 3 类 | | |
| MUR | Graft, Sclera, Reinforcement | 第 3 类 | | |
| MUZ | Stimulator, Autonomic Nerve, Implanted (Depression) | 第 3 类 | | |
| MVC | System, Test, Her-2/Neu, Ihc | 第 3 类 | | |
| MVD | System, Test, Her-2/Neu, Nucleic Acid Or Serum | 第 3 类 | | |
| MVF | System, Laser, Photodynamic Therapy | 第 3 类 | | |
| MVG | System, Laser, Fiber Optic, Photodynamic Therapy | 第 3 类 | | |
| MVK | Wearable Automated External Defibrillator | 第 3 类 | | |
| MVL | Cord, Retraction | 第 U 类 | | 36 |
| MVO | Kit, Test, Multiple, Drugs Of Abuse, Over The Counter | 第 U 类 | | 18 |
| MVV | Device, Acupressure | 第 U 类 | | 13 |
| MVW | Kit, Western Blot, Hiv-1 | 第 N 类 | | |
| MVX | Antibody, Monoclonal Blocking, Hiv-1 | 第 N 类 | | |
| MVY | Monoclonal, Hiv-1 | 第 N 类 | | |
| MVZ | System, Test, Home, Hiv-1 | 第 3 类 | | |
| MWB | Kit, Test, Saliva, Hiv-1&2 | 第 3 类 | | |
| MWD | Electrosurgical, Radio Frequency, Refractive Correction | 第 3 类 | | |
| MWG | System, Oxygen, Aqueous | 第 3 类 | | |
| MWH | Pulmonic Valved Conduit | 第 F 类 | | |
| MWM | Sensor, Electro-Optical (For Cervical Cancer) | 第 3 类 | | |
| MWO | Reagent, Blood Bank, Quality Control | 第 N 类 | | |
| MWQ | System, Test, Total Antioxidant Status | 第 3 类 | | |
| MXM | Cap, Cooling (Infants) | 第 3 类 | | |
| MXQ | Stent, Urethral, External Sphincter, Permanent | 第 3 类 | | |
| MYH | System, Non-Coherent Light, Photodynamic Therapy | 第 3 类 | | |
| MYK | Kit, Cord Blood Collection | 第 N 类 | | |
| MYL | Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg | 第 3 类 | | |
| MYM | Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm | 第 3 类 | | |
| MYP | Test, Platelet Antibody | 第 2 类 | | |
| MYS | Device, Ahf, Automated Cryoprecipitation | 第 N 类 | | |
| MYW | Irradiation, Blood Indicators | 第 N 类 | | |
| MYY | Separator, Semi-Automated, Blood Component | 第 1 类 | | |
| MYZ | Kit, Test (Donors), For Bloodborne Pathogen | 第 2 类 | | |
| MZA | Test, Equipment, Automated Bloodborne Pathogen | 第 N 类 | | |
| MZE | Test, Donor, Cmv | 第 2 类 | | |
| MZH | Test, Quantitative, For Hla, Non-Diagnostic | 第 N 类 | | |
| MZI | Test, Qualitative, For Hla, Non-Diagnostic | 第 U 类 | | |
| MZK | System, Separation, Hematopoietic Stem Cell | 第 3 类 | | |
| MZL | Kit, Test, Quality Control For Endotoxin | 第 N 类 | | |
| NAF | Antigen(Complexed),Prostate Specific,(Cpsa) | 第 3 类 | | |
| NAH | System, Test, Tumor Marker, For Detection Of Bladder Cancer | 第 3 类 | | |
| NAN | Tester, Acoustic, Bone Quality | 第 3 类 | | |
| NAP | Cardiac Support Mesh Wrap | 第 N 类 | | |
| NAV | Graft, Bypass, Coronary Artery | 第 F 类 | | |
| NAW | Microspheres Radionuclide | 第 3 类 | | |
| NAZ | Stimulator, Bladder | 第 F 类 | | |
| NBE | Sealant, Polymerizing | 第 3 类 | | |
| NBF | Prosthesis, Retinal | 第 F 类 | | |
| NBN | Generator, Shock-Wave, For Pain Relief | 第 3 类 | | |
| NCD | Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis | 第 3 类 | | |
| NCJ | Telescope, Implantable, Miniature | 第 3 类 | | |
| NCL | Imager, Breast, Electrical Impedance | 第 3 类 | | |
| NCO | Implant, Cartilage, For Articular Cartilage Repair | 第 3 类 | | |
| NCT | Instrument, Glucose, Noninvasive Technology | 第 3 类 | | |
| NCV | Lithotripter, Shockwave (For Treating Gallbladder Stones) | 第 3 类 | | |
| NDV | Test, Ecarin Clotting Time (Ect) | 第 F 类 | | |
| NEG | Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis | 第 3 类 | | |
| NEK | Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffol | 第 3 类 | | |
| NGM | Test, Phencyclidine (Pcp), Over The Counter | 第 U 类 | | |
| NGV | System, Appendage Closure, Left Atrial | 第 3 类 | | |
| NHL | Stimulator, Electrical, Implanted, For Parkinsonian Symptoms | 第 3 类 | | |
| NIK | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resync | 第 3 类 | | |
| NIM | Stent, Carotid | 第 3 类 | | |
| NIN | Stent, Renal | 第 3 类 | | |
| NIO | Stent, Iliac | 第 3 类 | | |
| NIP | Stent, Superficial Femoral Artery | 第 3 类 | | |
| NIQ | Coronary Drug-Eluting Stent | 第 3 类 | | |
| NIU | Stent, Superficial Femoral Artery, Drug-Eluting | 第 3 类 | | |
| NIV | Coronary Covered Stent | 第 F 类 | | |
| NJE | Intracranial Neurovascular Stent | 第 F 类 | | |
| NJK | Valve, Pulmonary | 第 3 类 | | |
| NJL | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer | 第 3 类 | | |
| NKE | Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronizatio | 第 3 类 | | |
| NKM | Mitral Valve Repair Devices | 第 3 类 | | |
| NLQ | Single-Use Reprocessed Ultrasonic Surgical Instruments | 第 U 类 | | 27 |
| NOX | Filler, Bone Void, Synthetic Peptide | 第 3 类 | | |
| NPE | Material, Embolization, Neurovascular, Polymerizing Or Precipitating | 第 3 类 | | |
| NPS | Tricuspid Valve Repair Device, Percutaneously Delivered | 第 3 类 | | |
| NPT | Aortic Valve, Prosthesis, Percutaneously Delivered | 第 3 类 | | |
| NPU | Prosthesis, Mitral Valve, Percutaneously Delivered | 第 3 类 | | |
| NPV | Pulmonary Valve Prosthesis Percutaneously Delivered | 第 F 类 | | |
| NPW | Percutaneously Delivered Prostheses And Tricuspid Valves | 第 3 类 | | |
| NQC | Test, Breath Analysis, Volatile Organic Compounds | 第 F 类 | | |
| NQK | Maggots, Medical | 第 U 类 | | 6 |
| NQO | Prosthesis, Spinous Process Spacer/Plate | 第 3 类 | | |
| NQR | Sealant, Dural | 第 3 类 | | |
| NRA | Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Me | 第 3 类 | | |
| NRN | Leeches, Medicinal | 第 U 类 | | 3 |
| NRZ | Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided | 第 3 类 | | |
| NSD | Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer De | 第 3 类 | | |
| NSJ | Restoration, Noble Metal | 第 N 类 | | |
| NSK | Dentures, Partial | 第 N 类 | | |
| NSL | Dentures, Full | 第 N 类 | | |
| NSM | Restoration, Resin | 第 N 类 | | |
| NSN | Restoration, Resin, Crown And Bridge | 第 N 类 | | |
| NSO | Restoration, Porcelain-Fused-To-Metal | 第 N 类 | | |
| NSP | Restoration, Porcelain | 第 N 类 | | |
| NSQ | Restoration, Base Metal | 第 N 类 | | |
| NSR | Prosthesis, Orthodontic | 第 N 类 | | |
| NSS | Electronic Media, Nausea | 第 N 类 | | |
| NTG | Prosthesis, Ankle, Uncemented, Non-Constrained | 第 3 类 | | |
| NUK | For Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody | 第 N 类 | | |
| NUL | For Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibod | 第 N 类 | | |
| NVN | Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pac | 第 3 类 | | |
| NVR | Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar | 第 3 类 | | 6 |
| NVY | Permanent Defibrillator Electrodes | 第 3 类 | | |
| NVZ | Pulse Generator, Permanent, Implantable | 第 3 类 | | |
| NWX | Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutti | 第 3 类 | | |
| NWY | Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies | 第 N 类 | | |
| NXG | Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Ampli | 第 3 类 | | |
| NXJ | Denture, Cosmetic Only | 第 N 类 | | |
| NXT | Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing | 第 3 类 | | |
| NXW | Scaffold, Infrapopliteal, Absorbable | 第 3 类 | | |
| NYQ | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Ne | 第 3 类 | | |
| NZC | Stent, Urethral, Prostatic, Semi-Permanent | 第 3 类 | | |
| NZF | Static Electricity-Emitting Device, Cosmetic Use | 第 N 类 | | |
| NZK | Stimulator, Low Electric Field, Tumor Treatment | 第 3 类 | | |
| OAA | Aid, Visual, For Nausea | 第 N 类 | | |
| OAD | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flut | 第 3 类 | | |
| OAE | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibr | 第 3 类 | | |
| OAF | Implant, Hearing, Active, Middle Ear, Totally Implanted | 第 3 类 | | |
| OAQ | Electronic Media, Hyperacusis | 第 N 类 | | |
| OAW | Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Ep | 第 F 类 | | |
| OAY | Light Source System, Diagnostic Endoscopic | 第 3 类 | | |
| OAZ | One-Way Air-Leak Valve | 第 F 类 | | |
| OBA | Polymerizing, Neurovascular Embolization Material | 第 F 类 | | |
| OBC | Occluder, Internal Vessel, Temporary | 第 3 类 | | |
| OBD | Barrier, Adhesion, Cardiovascular | 第 3 类 | | |
| OBR | Mouthguard, Over-The-Counter | 第 U 类 | | 46 |
| OCB | Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastas | 第 3 类 | | |
| OCE | Cultured Epithelial Autograft | 第 F 类 | | |
| OCK | Transurethral Occlusion Insert, Urinary Incontinence-Control, Female | 第 3 类 | | |
| OCM | Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation | 第 3 类 | | |
| OCO | Mouthguard, Migraine/Tension Headache | 第 U 类 | | 3 |
| ODH | Implantable Bladder-Evacuation Electrical Stimulation System | 第 F 类 | | |
| ODK | Refractive Corneal Implant | 第 F 类 | | |
| ODS | Wound Covering (Composite Cultured Skin) | 第 F 类 | | |
| ODT | Tissue Adhesive, Aortic Aneurysmorrhaphy | 第 F 类 | | |
| OEE | Diagnostic Low Electric Field | 第 3 类 | | |
| OGO | Intraocular Pressure Lowering Implant | 第 3 类 | | |
| OHA | Heart Valve, More Than Minimally Manipulated Allograft | 第 U 类 | | 4 |
| OIH | Yersinia Spp. Reagents | 第 U 类 | | 1 |
| OIR | Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator | 第 3 类 | | |
| OJE | Right Ventricular Bypass (Assist) Device | 第 F 类 | | |
| OJI | Burn Kit With Drug | 第 N 类 | | |
| OJN | Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Link | 第 3 类 | | |
| OJO | Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomann | 第 N 类 | | |
| OJX | Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode | 第 3 类 | | |
| OJZ | Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffol | 第 F 类 | | |
| OKD | Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffol | 第 F 类 | | |
| OKN | Hyperthermia System, Bladder Cancer Treatment, With Chemotherapy | 第 3 类 | | |
| OKS | Lacrimal Stents And Intubation Sets | 第 U 类 | | 31 |
| OLM | Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd) | 第 F 类 | | |
| OLQ | Cross-Sectional Mammographic Xray System | 第 3 类 | | |
| OLR | Oral Wound Dressing | 第 U 类 | | 43 |