| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| BSD | Analyzer, Gas, Nitrogen, Partial Pressure, Blood-Phase, Non-Indwelling | 第 3 类 | | |
| BWK | Stimulator, Electro-Acupuncture | 第 U 类 | | 23 |
| DSQ | Ventricular (Assist) Bypass | 第 3 类 | | |
| DTH | Suture, Cardiovascular | 第 3 类 | | |
| DZG | Suture, Dental | 第 3 类 | | |
| EFQ | Gauze/Sponge, Internal | 第 U 类 | | 271 |
| EPG | Stimulator, Transdermal | 第 3 类 | | |
| ESI | Polymer, Natural-Absorbable Gelatin Material | 第 3 类 | | 2 |
| EWD | Protector, Hearing (Insert) | 第 U 类 | | 14 |
| EWE | Protector, Hearing (Circumaural) | 第 U 类 | | 1 |
| EZZ | Prosthesis, Vas Deferens | 第 3 类 | | 1 |
| FAA | Replacer, Urethral | 第 3 类 | | 1 |
| FAB | Replacer, Ureteral | 第 3 类 | | |
| FAC | Valve, Ureterovesicle | 第 3 类 | | |
| FAG | Prosthesis, Urethral Sphincter | 第 3 类 | | 2 |
| FAO | Device, Cystometric, Air | 第 3 类 | | |
| FBY | Cooler, Esophageal And Gastric | 第 3 类 | | |
| FBZ | Cooler, Prostatic | 第 3 类 | | |
| FRO | Dressing, Wound, Drug | 第 U 类 | | 707 |
| FZC | Prosthesis, Arterial Graft, Bovine Carotid Artery | 第 3 类 | | |
| HHY | Prosthesis, Suture, Cerclage | 第 3 类 | | |
| HMN | Suture, Nonabsorable, Ophthalmic | 第 3 类 | | 1 |
| HMO | Suture, Absorbable, Ophthalmic | 第 3 类 | | |
| HPX | Lens, Contact (Polymethylmethacrylate) | 第 U 类 | | 74 |
| HTM | Stimulator, Osteogenesis, Electric, Battery-Operated, Invasive | 第 3 类 | | |
| HWF | Prosthesis, Ligament | 第 3 类 | | |
| KGF | Adhesive, Tissue For Aneurysmorrhaphy | 第 3 类 | | 1 |
| KGG | Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malform | 第 3 类 | | |
| KGM | Silicone, Liquid, Injectable | 第 3 类 | | |
| KGN | Wound Dressing With Animal-Derived Material(S) | 第 U 类 | | 191 |
| KJJ | Cleanser, Root Canal | 第 U 类 | | 41 |
| KSJ | System, Identification, Hepatitis B Antigen | 第 3 类 | | |
| KTA | Medium, Contrast, Radiologic | 第 U 类 | | 8 |
| KTJ | System, Test, Alpha-Fetoprotein, Ria | 第 3 类 | | |
| LAO | Enzyme Immunoassay, Methotrexate | 第 U 类 | | 10 |
| LBK | Neurosurgical Ultrasonic Instruments | 第 U 类 | | 7 |
| LCJ | Tissue Expander And Accessories | 第 U 类 | | 55 |
| LCL | Radioimmunoassay, Phencyclidine | 第 U 类 | | 11 |
| LCM | Enzyme Immunoassay, Phencyclidine | 第 U 类 | | 88 |
| LDK | Device, Sensing, Optical Contour | 第 U 类 | | 8 |
| LEI | Implant, Anti-Gastroesophageal Reflux | 第 3 类 | | |
| LEZ | Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient | 第 U 类 | | 3 |
| LFA | Aids, Speech Training For The Hearing Impaired (Battery-Operated Or No | 第 U 类 | | 2 |
| LFB | Button, Nasal Septal | 第 U 类 | | 12 |
| LFD | Saliva, Artificial | 第 U 类 | | 50 |
| LFL | Instrument, Ultrasonic Surgical | 第 U 类 | | 158 |
| LGW | Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | 第 3 类 | | |
| LHD | Device, Fertility Diagnostic, Proceptive | 第 U 类 | | 24 |
| LHE | Controller, Closed-Loop Blood Glucose | 第 3 类 | | |
| LHY | Electrode, Stabilized Epidural Spinal | 第 3 类 | | |
| LII | Monitor, Intracranial Pressure, Implanted | 第 3 类 | | |
| LIL | Monitor, Penile Tumescence | 第 U 类 | | 26 |
| LIW | Fibrillator, Ac | 第 U 类 | | |
| LJE | Catheter, Nephrostomy | 第 U 类 | | 56 |
| LKB | Pad, Alcohol, Device Disinfectant | 第 U 类 | | 25 |
| LKK | Pump, Infusion, Implanted, Programmable | 第 3 类 | | |
| LKN | Separator, Automated, Blood Cell And Plasma, Therapeutic | 第 U 类 | | 27 |
| LKV | Enzyme Immunoassay, Fetal Fibronectin | 第 3 类 | | |
| LKW | Laser, Neurosurgical | 第 3 类 | | 5 |
| LKX | Device, Thermal, Hemorrhoids | 第 U 类 | | 18 |
| LLE | Stimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease | 第 3 类 | | 2 |
| LLF | Laser, Neurosurgical, Argon | 第 3 类 | | 4 |
| LLP | Laser For Pain Therapy | 第 3 类 | | |
| LLQ | Cap, Cervical, Contraceptive | 第 3 类 | | |
| LLX | Catheter, Sampling, Chorionic Villus | 第 3 类 | | |
| LME | Monitor, Blood-Flow, Cerebral, Thermal Diffusion | 第 3 类 | | 1 |
| LMH | Implant, Dermal, For Aesthetic Use | 第 3 类 | | |
| LMI | Implant, Collagen For Non-Aesthetic Use | 第 3 类 | | |
| LML | Ligaments And Tendons, Synthetic | 第 3 类 | | |
| LMN | Ceramics, Calcium Triphosphate/Hydroxypatite, Non-Load Bearing Uses | 第 3 类 | | |
| LMQ | Device, Peritoneal Access, Subcutaneous, Implanted | 第 3 类 | | 1 |
| LMW | Solution, Removal, Carries | 第 3 类 | | |
| LMY | Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions | 第 3 类 | | |
| LMZ | Applicator, Hyperthermia, Interstitial | 第 3 类 | | |
| LNB | Applicator, Hyperthermia, Deep Heating, Ultrasound | 第 3 类 | | |
| LNC | Applicator, Hyperthermia, Superficial, Rf/Microwave | 第 3 类 | | |
| LNL | Stimulator, Electrical For Sperm Collection | 第 U 类 | | 1 |
| LNM | Agent, Bulking, Injectable For Gastro-Urology Use | 第 3 类 | | |
| LNQ | Intestinal Stimulator | 第 F 类 | | |
| LNR | System, Photopheresis, Extracorporeal | 第 3 类 | | |
| LNY | Catheter, Percutaneous, Long Term, Intraspinal | 第 3 类 | | |
| LOA | Device, Testicular Hypothermia | 第 3 类 | | |
| LOB | Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination | 第 3 类 | | |
| LOC | System, Rf/Microwave Hyperthermia, Cancer Treatment | 第 3 类 | | |
| LOE | Stimulator, Invasive Bone Growth | 第 3 类 | | |
| LOG | Catheter, Balloon For Retinal Reattachment | 第 3 类 | | |
| LOH | System, Identification, Contact Lens | 第 3 类 | | |
| LOI | Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulo | 第 3 类 | | 1 |
| LOK | Kit, Test, Alpha-Fetoprotein For Neural Tube Defects | 第 3 类 | | |
| LOT | Pulse-Generator, Program Module | 第 3 类 | | |
| LOZ | Artificial Heart | 第 3 类 | | |
| LPA | System, Esophageal Pacing | 第 3 类 | | |
| LPB | Cardiac Ablation Percutaneous Catheter | 第 3 类 | | |
| LPC | Device, Angioplasty, Laser, Coronary | 第 3 类 | | |
| LPF | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented | 第 3 类 | | |
| LPG | Material, Dressing, Surgical, Polylactic Acid | 第 3 类 | | |
| LPZ | Container, Frozen Donor Tissue Storage | 第 U 类 | | 6 |
| LQB | Medical Computers And Software For Ophthalmic Use | 第 3 类 | | 2 |
| LQD | Recorder, Attention Task Performance | 第 U 类 | | 11 |
| LQE | Implant, Corneal, Refractive | 第 3 类 | | |
| LQI | Hepatitis Delta Serological Reagents | 第 3 类 | | |
| LQQ | Columns, Immunoadsorption In Extracorporeal Systems | 第 3 类 | | 1 |
| LQS | Spermatocele, Alloplastic | 第 U 类 | | 1 |
| LQY | Locator, Root Apex | 第 U 类 | | 46 |
| LRA | Hearing Aid, Tactile | 第 U 类 | | 8 |
| LRL | Cushion, Hemorrhoid | 第 U 类 | | 3 |
| LRQ | Tracheostomy And Nasal Suctioning Kit | 第 1 类 | | 6 |
| LRR | First Aid Kit With Drug | 第 N 类 | | 15 |
| LSX | Controller, Closed-Loop, Blood-Pressure | 第 3 类 | | |
| LSY | Ultrasound, Hyperthermia, Cancer Treatment | 第 3 类 | | |
| LSZ | Ventilator, High Frequency | 第 3 类 | | |
| LTA | Fluid, Hysteroscopy | 第 3 类 | | |
| LTC | Hyaline Membrane Disease Assay | 第 3 类 | | 1 |
| LTD | Paraquat Assay | 第 3 类 | | 2 |
| LTG | Paste, Injectable For Vocal Cord Augmentation | 第 3 类 | | |
| LTI | Implant, Intragastric For Morbid Obesity | 第 3 类 | | |
| LTQ | Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum | 第 3 类 | | |
| LTY | Fluid, Cytological Collection | 第 3 类 | | |
| LWA | Prosthesis, Ligament, Ptfe | 第 3 类 | | |
| LWB | Stimulator, Functional Neuromuscular, Scoliosis | 第 3 类 | | |
| LWE | Bone Marrow Collection/Transfusion Kit | 第 2 类 | | 3 |
| LWM | Device, Electrical Dental Anesthesia | 第 U 类 | | 15 |
| LWO | Pulse-Generator, Single Chamber, Sensor Driven, Implantable | 第 3 类 | | |
| LWP | Implantable Pulse Generator, Pacemaker (Non-Crt) | 第 3 类 | | |
| LWQ | Heart-Valve, Mechanical | 第 3 类 | | |
| LWR | Heart-Valve, Non-Allograft Tissue | 第 3 类 | | |
| LWS | Implantable Cardioverter Defibrillator (Non-Crt) | 第 3 类 | | |
| LWT | Occluder, Balloon, Vena-Cava | 第 3 类 | | |
| LWW | Pulse-Generator, Single Chamber, Single | 第 3 类 | | |
| LWX | Device. Laser Peripheral Angioplasty | 第 3 类 | | |
| LWZ | Tissue Graft Of Less Than 6mm | 第 3 类 | | 2 |
| LXA | Tissue Graft Of 6mm And Greater | 第 3 类 | | |
| LXC | Monitor, Pressure, Intracompartmental | 第 U 类 | | 15 |
| LXM | Manipulator, Plunger-Like Joint | 第 U 类 | | 32 |
| LXQ | Cup, Eye | 第 U 类 | | 5 |
| LXU | Laser For Wound Healing | 第 3 类 | | |
| LXV | Apparatus, Vestibular Analysis | 第 U 类 | | 22 |
| LXW | Column, Adsorption, Low Density, Lipoprotein | 第 3 类 | | 1 |
| LXY | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, | 第 3 类 | | |
| LYI | Stimulator, Subcortical, Implanted For Epilepsy | 第 3 类 | | |
| LYJ | Stimulator, Autonomic Nerve, Implanted For Epilepsy | 第 3 类 | | |
| LYX | Media, Corneal Storage | 第 U 类 | | 21 |
| LZJ | Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Cons | 第 U 类 | | 11 |
| LZQ | Tissue Adhesive For Ophthalmic Use | 第 3 类 | | |
| LZS | Excimer Laser System | 第 3 类 | | |
| LZU | Plug, Punctum | 第 U 类 | | 49 |
| LZW | Monitor, Spine Curvature | 第 U 类 | | 5 |
| MAD | Catheter, Percutaneous (Valvuloplasty) | 第 3 类 | | |
| MAE | Occluder, Patent Ductus, Arteriosus | 第 3 类 | | |
| MAF | Stent, Coronary | 第 3 类 | | |
| MAN | Assay, Interleukin | 第 3 类 | | |
| MAO | Dna-Probe, Human Chromosome | 第 U 类 | | |
| MAQ | Kit, Dna Detection, Human Papillomavirus | 第 3 类 | | |
| MBD | Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Por | 第 3 类 | | |
| MBJ | Fastener, Fixation, Biodegradable, Hard Tissue | 第 3 类 | | 1 |
| MBQ | Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing | 第 3 类 | | |
| MBS | Filler, Bone Void, Non-Osteoinduction | 第 3 类 | | |
| MBX | Stimulator, Thalamic, Epilepsy, Implanted | 第 3 类 | | |
| MCI | Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite | 第 3 类 | | |
| MCL | Kit, Test, In Vitro Periodontal | 第 3 类 | | |
| MCM | Implant, Cochlear | 第 3 类 | | |
| MCN | Barrier, Absorbable, Adhesion | 第 3 类 | | |
| MCP | Stimulator, Fetal, Acoustic | 第 3 类 | | |
| MCV | Spinal Pedicle Screw, Fixation, Appliance System | 第 3 类 | | |
| MCX | Catheter, Coronary, Atherectomy | 第 3 类 | | |
| MDD | Device, Dermal Replacement | 第 3 类 | | |
| MDP | Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plas | 第 3 类 | | |
| MDS | Sensor, Glucose, Invasive | 第 3 类 | | |
| MEQ | System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Ther | 第 3 类 | | |
| MER | Stent, Urethral, Prostatic, Permanent Or Semi-Permanent | 第 3 类 | | |
| MES | Stent, Urethral, Bulbous, Permanent Or Semi-Permanent | 第 3 类 | | |
| MFA | Device, Removal, Pacemaker Electrode, Percutaneous | 第 3 类 | | |
| MFE | Agent, Injectable, Embolic | 第 3 类 | | |
| MFR | Stimulator, Brain, Implanted, For Behavior Modification | 第 F 类 | | |
| MGB | Device, Hemostasis, Vascular | 第 3 类 | | |
| MGI | Aspirator, Ultrasonic | 第 3 类 | | 1 |
| MGP | Dressing, Wound And Burn, Occlusive | 第 U 类 | | 80 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 第 U 类 | | 145 |
| MGR | Dressing, Wound And Burn, Interactive | 第 3 类 | | |
| MGX | Test System, For Drugs Of Abuse | 第 3 类 | | |
| MHE | Implant, Auditory Brainstem | 第 3 类 | | |
| MHR | Test, Anti-Tumor Cell Susceptibility | 第 3 类 | | |
| MHY | Stimulator, Electrical, Implanted, For Parkinsonian Tremor | 第 3 类 | | |
| MHZ | Stimulator, Vestibular Acceleration, Therapeutic | 第 3 类 | | 1 |
| MIE | Heart-Valve, Allograft | 第 3 类 | | |
| MIG | Strip, Test Isoniazid | 第 U 类 | | 2 |
| MIH | System, Endovascular Graft, Aortic Aneurysm Treatment | 第 3 类 | | |
| MIK | Device, Ultrasonic, Thermal Ablation | 第 3 类 | | |
| MIP | Implanted Fecal Incontinence Device | 第 3 类 | | |
| MIR | Shunt, Portosystemic, Endoprosthesis | 第 3 类 | | |
| MJB | Antigen, Cancer 549 | 第 3 类 | | |
| MJO | Prosthesis, Intervertebral Disc | 第 3 类 | | |
| MJS | Contrast Media, Ultrasound | 第 3 类 | | |
| MJT | Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, C | 第 3 类 | | 3 |
| MJV | Device, Inflation, Middle Ear | 第 U 类 | | 6 |
| MKD | Stimulator, Functional Walking Neuromuscular, Non-Invasive | 第 3 类 | | |
| MKN | Catheter, Balloon, Transcervical | 第 3 类 | | |
| MKQ | Processor, Cervical Cytology Slide, Automated | 第 3 类 | | |
| MLQ | Inhibitor, Peridural Fibrosis (Adhesion Barrier) | 第 3 类 | | |
| MLV | Transcatheter Septal Occluder | 第 3 类 | | |