| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| HCF | Instrument, Ligature Passing And Knot Tying | 第 1 类 | 21 CFR 878.4800 | 5 |
| HJE | Lamp, Fluorescein, Ac-Powered | 第 2 类 | 21 CFR 878.4580 | 3 |
| HMP | Pad, Eye | 第 1 类 | 21 CFR 878.4440 | 17 |
| HMT | Drape, Patient, Ophthalmic | 第 2 类 | 21 CFR 878.4370 | 7 |
| HMW | Drape, Microscope, Ophthalmic | 第 2 类 | 21 CFR 878.4370 | 4 |
| HRB | Microscope, Operating, Non-Electric, Ophthalmic | 第 1 类 | 21 CFR 878.4700 | |
| HRM | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | 第 1 类 | 21 CFR 878.4700 | 14 |
| HRQ | Hemostat | 第 1 类 | 21 CFR 878.4800 | 15 |
| HSO | Saw | 第 1 类 | 21 CFR 878.4800 | |
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attach | 第 1 类 | 21 CFR 878.4820 | 56 |
| HTC | Pliers, Surgical | 第 1 类 | 21 CFR 878.4800 | 10 |
| HTD | Forceps | 第 1 类 | 21 CFR 878.4800 | 73 |
| HTE | Elevator | 第 1 类 | 21 CFR 878.4800 | |
| HTF | Curette | 第 1 类 | 21 CFR 878.4800 | 3 |
| HTR | Rasp | 第 1 类 | 21 CFR 878.4800 | 9 |
| HTZ | Instrument, Cutting, Orthopedic | 第 1 类 | 21 CFR 878.4800 | 21 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attac | 第 1 类 | 21 CFR 878.4820 | 76 |
| HWM | Osteotome | 第 1 类 | 21 CFR 878.4800 | 3 |
| HXD | Clamp | 第 1 类 | 21 CFR 878.4800 | 14 |
| HXL | Mallet | 第 1 类 | 21 CFR 878.4800 | 3 |
| HXR | Spatula, Orthopedic | 第 1 类 | 21 CFR 878.4800 | 4 |
| HXT | Tape, Orthopedic | 第 1 类 | 21 CFR 878.4800 | |
| HYA | Forceps, Wire Holding | 第 1 类 | 21 CFR 878.4800 | |
| JCQ | Prosthesis, Esophagus | 第 2 类 | 21 CFR 878.3610 | 1 |
| JCT | Prosthesis, Tracheal, Expandable | 第 2 类 | 21 CFR 878.3720 | 45 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 第 2 类 | 21 CFR 878.4780 | 77 |
| JCY | Catheter, Infusion | 第 1 类 | 21 CFR 878.4200 | 14 |
| JDJ | Mesh, Surgical, Acetabular, Hip, Prosthesis | 第 2 类 | 21 CFR 878.3300 | 7 |
| JDK | Prosthesis, Hip, Cement Restrictor | 第 2 类 | 21 CFR 878.3300 | 54 |
| JEA | Table, Surgical With Orthopedic Accessories, Ac-Powered | 第 1 类 | 21 CFR 878.4960 | 10 |
| JEB | Table, Surgical With Orthopedic Accessories, Manual | 第 1 类 | 21 CFR 878.4950 | 13 |
| JOS | Electrode, Electrosurgical | 第 2 类 | 21 CFR 878.4400 | 36 |
| JOT | Electrode, Gel, Electrosurgical | 第 2 类 | 21 CFR 878.4400 | 9 |
| JYC | Cannula, Ear | 第 1 类 | 21 CFR 878.4800 | 2 |
| JYD | Chisel, Mastoid | 第 1 类 | 21 CFR 878.4800 | 1 |
| JYK | Holder, Ear Speculum | 第 1 类 | 21 CFR 878.1800 | 1 |
| KAG | Holder, Speculum, Ent | 第 1 类 | 21 CFR 878.1800 | 2 |
| KAM | Cannula, Sinus | 第 1 类 | 21 CFR 878.4800 | 19 |
| KAN | Chisel, Nasal | 第 1 类 | 21 CFR 878.4800 | |
| KCE | Cannulae, Bronchial | 第 1 类 | 21 CFR 878.4800 | |
| KCW | Epilator, High Frequency, Needle-Type | 第 1 类 | 21 CFR 878.5350 | 43 |
| KCX | Epilator, High Frequency, Tweezer-Type | 第 1 类 | 21 CFR 878.5360 | 25 |
| KCY | Tourniquet, Pneumatic | 第 1 类 | 21 CFR 878.5910 | 34 |
| KCZ | Prosthesis, Breast, External, Used With Adhesive | 第 1 类 | 21 CFR 878.3800 | 13 |
| KDA | Prosthesis, Ptfe/Carbon-Fiber | 第 2 类 | 21 CFR 878.3500 | 1 |
| KDC | Instrument, Surgical, Disposable | 第 1 类 | 21 CFR 878.4800 | 67 |
| KDD | Kit, Surgical Instrument, Disposable | 第 1 类 | 21 CFR 878.4800 | 62 |
| KDG | Chisel (Osteotome) | 第 1 类 | 21 CFR 878.4820 | 11 |
| KFK | Saw, Pneumatically Powered | 第 1 类 | 21 CFR 878.4820 | 4 |
| KGL | Cabinet, Phototherapy (Puva) | 第 2 类 | 21 CFR 878.4630 | 8 |
| KGO | Surgeon'S Gloves | 第 1 类 | 21 CFR 878.4460 | 560 |
| KGQ | Cream, Gloving, Surgeon'S | 第 1 类 | 21 CFR 878.4470 | 1 |
| KGS | Retention Device, Suture | 第 1 类 | 21 CFR 878.4930 | 20 |
| KGT | Drape, Adhesive, Aerosol | 第 1 类 | 21 CFR 878.4380 | 1 |
| KGW | Ring (Wound Protector), Drape Retention, Internal | 第 2 类 | 21 CFR 878.4370 | 9 |
| KGY | Bag, Intestine | 第 1 类 | 21 CFR 878.4100 | 6 |
| KGZ | Accessories, Catheter | 第 1 类 | 21 CFR 878.4200 | 29 |
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attac | 第 1 类 | 21 CFR 878.4820 | 29 |
| KIK | Hook, Bone | 第 1 类 | 21 CFR 878.4800 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 第 2 类 | 21 CFR 878.4370 | 450 |
| KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial R | 第 2 类 | 21 CFR 878.3500 | 25 |
| KOX | Solvent, Adhesive Tape | 第 1 类 | 21 CFR 878.4730 | 12 |
| KOY | Degreaser, Skin, Surgical | 第 1 类 | 21 CFR 878.4730 | |
| KOZ | Beads, Hydrophilic, For Wound Exudate Absorption | 第 1 类 | 21 CFR 878.4018 | 22 |
| KPJ | Chamber, Oxygen, Topical, Extremity | 第 2 类 | 21 CFR 878.5650 | 23 |
| KPK | Marker, Ostia, Aorto-Saphenous Vein | 第 2 类 | 21 CFR 878.4650 | 6 |
| KQM | Camera, Surgical And Accessories | 第 1 类 | 21 CFR 878.4160 | 18 |
| LEJ | Booth, Sun Tan | 第 2 类 | 21 CFR 878.4635 | 81 |
| LGX | Table, Examination, Medical, Powered | 第 1 类 | 21 CFR 878.4960 | 14 |
| LMF | Agent, Absorbable Hemostatic, Collagen Based | 第 3 类 | 21 CFR 878.4490 | |
| LMG | Agent, Absorbable Hemostatic, Non-Collagen Based | 第 3 类 | 21 CFR 878.4490 | |
| LNK | Laser For Gastro-Urology Use | 第 2 类 | 21 CFR 878.4810 | 60 |
| LRO | General Surgery Tray | 第 2 类 | 21 CFR 878.4370 | 110 |
| LRP | Tray, Surgical | 第 1 类 | 21 CFR 878.4800 | 22 |
| LRW | Scissors, General, Surgical | 第 1 类 | 21 CFR 878.4800 | 18 |
| LRY | Punch, Surgical | 第 1 类 | 21 CFR 878.4800 | 7 |
| LRZ | Screwdriver, Surgical | 第 1 类 | 21 CFR 878.4800 | 3 |
| LSA | Vise, Bench, Surgical | 第 1 类 | 21 CFR 878.4800 | 1 |
| LWG | Surgical Table Cushion | 第 1 类 | 21 CFR 878.4950 | 4 |
| LWK | Razor, Surgical | 第 1 类 | 21 CFR 878.4800 | 4 |
| LXI | Guide, Drill, Ligament | 第 1 类 | 21 CFR 878.4820 | 8 |
| LXK | Scrapper, Skin Specimen | 第 1 类 | 21 CFR 878.4800 | 1 |
| LXZ | Guard, Instrument | 第 1 类 | 21 CFR 878.4800 | 2 |
| LYU | Accessory, Surgical Apparel | 第 1 类 | 21 CFR 878.4040 | 56 |
| LYV | Label Or Tag, Sterile | 第 1 类 | 21 CFR 878.4800 | 2 |
| LZK | Implant, Malar | 第 2 类 | 21 CFR 878.3550 | 40 |
| LZM | Guard, Skin Graft | 第 1 类 | 21 CFR 878.4014 | 2 |
| LZN | Cement Obturator | 第 2 类 | 21 CFR 878.3300 | 37 |
| MAC | Decontamination Kit | 第 1 类 | 21 CFR 878.4014 | 2 |
| MAW | Marker, Suture Identification | 第 1 类 | 21 CFR 878.4800 | 1 |
| MCA | Tape, Surgical, Internal | 第 2 类 | 21 CFR 878.3300 | 1 |
| MCH | Clip, Hemostatic | 第 2 类 | 21 CFR 878.4300 | 3 |
| MCZ | Suture Removal Kit | 第 1 类 | 21 CFR 878.4800 | 15 |
| MDA | Elastomer, Silicone, For Scar Management | 第 1 类 | 21 CFR 878.4025 | 81 |
| MDM | Instrument, Manual, Surgical, General Use | 第 1 类 | 21 CFR 878.4800 | 44 |
| MGO | Closure, Wound, Adhesive | 第 1 类 | 21 CFR 878.4018 | 1 |
| MIJ | Needle, Tumor Localization | 第 1 类 | 21 CFR 878.4800 | |
| MJG | Device, Percutaneous, Biopsy | 第 1 类 | 21 CFR 878.4800 | 7 |
| MKY | System, Skin Closure | 第 1 类 | 21 CFR 878.4320 | 6 |
| MMP | Cover, Barrier, Protective | 第 2 类 | 21 CFR 878.4370 | 15 |
| MNF | Implant, Temporal | 第 2 类 | 21 CFR 878.3550 | 2 |
| MOQ | Battery, Replacement, Rechargeable | 第 1 类 | 21 CFR 878.4820 | 3 |
| MPN | Tissue Adhesive For The Topical Approximation Of Skin | 第 2 类 | 21 CFR 878.4010 | 36 |
| MQR | Stent, Colonic, Metallic, Expandable | 第 2 类 | 21 CFR 878.3610 | 16 |
| MSA | Dressing, Wound And Burn, Occlusive, Heated | 第 1 类 | 21 CFR 878.4020 | 2 |
| MSH | Respirator, Surgical | 第 2 类 | 21 CFR 878.4040 | 35 |
| MUK | Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Fe | 第 2 类 | 21 CFR 878.4400 | 3 |
| MUL | Generator, Electrosurgical, Coagulation, Cancer | 第 2 类 | 21 CFR 878.4400 | |
| MUM | Stent, Metallic, Expandable, Duodenal | 第 2 类 | 21 CFR 878.3610 | 6 |
| MUU | System, Suction, Lipoplasty | 第 2 类 | 21 CFR 878.5040 | 40 |
| MVR | Device, Anastomotic, Microvascular | 第 2 类 | 21 CFR 878.4300 | 9 |
| MWY | System, Microwave, Hair Removal | 第 2 类 | 21 CFR 878.4400 | 2 |
| MXG | Lamp, Uvc, (For Treating Skin And Wounds) | 第 2 类 | 21 CFR 878.4630 | 1 |
| MXW | Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride) | 第 2 类 | 21 CFR 878.5010 | 2 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | 第 1 类 | 21 CFR 878.4014 | 88 |
| NAC | Dressing, Wound, Hydrophilic | 第 1 类 | 21 CFR 878.4018 | 4 |
| NAD | Dressing, Wound, Occlusive | 第 1 类 | 21 CFR 878.4020 | 107 |
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic | 第 1 类 | 21 CFR 878.4022 | 29 |
| NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | 第 2 类 | 21 CFR 878.5035 | 17 |
| NCA | Clip, Implantable, For Coronary Artery Bypass Graft (Cabg) | 第 2 类 | 21 CFR 878.4300 | 3 |
| NEH | Anchor, Fascial | 第 2 类 | 21 CFR 878.4300 | 1 |
| NEJ | System, Cryosurgical, Liquid Nitrogen, For Gastroenterology | 第 2 类 | 21 CFR 878.4350 | |
| NEU | Marker, Radiographic, Implantable | 第 2 类 | 21 CFR 878.4300 | 110 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | 第 2 类 | 21 CFR 878.4840 | 66 |
| NEY | System, Ablation, Microwave And Accessories | 第 2 类 | 21 CFR 878.4400 | 68 |
| NJC | Clip, Vas Deferens | 第 2 类 | 21 CFR 878.4300 | 2 |
| NJU | Suture, Nonabsorbable, Nitinol | 第 2 类 | 21 CFR 878.4495 | 2 |
| NJZ | Extractor, Vein | 第 1 类 | 21 CFR 878.4800 | |
| NLK | Needle, Biopsy, Cardiovascular, Reprocessed | 第 1 类 | 21 CFR 878.4800 | |
| NLL | Staple, Implantable, Reprocessed | 第 2 类 | 21 CFR 878.4750 | 3 |
| NMJ | Clip, Implantable, Reprocessed | 第 2 类 | 21 CFR 878.4300 | 1 |
| NMT | Needle, Catheter, Reprocessed | 第 1 类 | 21 CFR 878.4200 | |
| NMU | Needle, Gastro-Urology, Reprocessed | 第 1 类 | 21 CFR 878.4800 | |
| NNA | Biopsy Device, Percutaneous, Reprocessed | 第 1 类 | 21 CFR 878.4800 | |
| NNC | Needle, Aspiration And Needle, Reprocessed | 第 1 类 | 21 CFR 878.4800 | |
| NOC | Splint, Extremity, Non-Inflatable, External, Non-Sterile | 第 1 类 | 21 CFR 878.3910 | |
| NOD | Board, Arm (With Cover), Non-Sterile | 第 1 类 | 21 CFR 878.3910 | |
| NOJ | Prosthesis, Breast, External, No Adhesive | 第 1 类 | 21 CFR 878.3800 | |
| NOK | Material, External Aesthetic Restoration, No Adhesive | 第 1 类 | 21 CFR 878.3800 | |
| NRB | Wound Cleaner, Ultrasound | 第 2 类 | 21 CFR 878.4410 | 9 |
| NRJ | Ultrasound, Skin Permeation | 第 2 类 | 21 CFR 878.4410 | 1 |
| NTB | System, Ablation, Ultrasound And Accessories | 第 2 类 | 21 CFR 878.4400 | 6 |
| NUJ | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & End | 第 2 类 | 21 CFR 878.4400 | 37 |
| NUV | Massager, Vacuum, Light Induced Heating | 第 2 类 | 21 CFR 878.4810 | 20 |
| NVH | Suture, Knot, Mechanical | 第 2 类 | 21 CFR 878.4300 | 1 |
| NVJ | Applicator, Transurethral, Radio Frequency, For Stress Urinary Inconti | 第 2 类 | 21 CFR 878.4400 | 1 |
| NVK | Laser, Dental, Soft Tissue | 第 2 类 | 21 CFR 878.4810 | 17 |
| NWA | Prosthesis, Tracheal, Preformed/Molded | 第 2 类 | 21 CFR 878.3720 | 7 |
| NWF | Drill, Battery Powered, Subungual Hematoma | 第 1 类 | 21 CFR 878.4820 | 1 |
| NWJ | Suture, Recombinant Technology | 第 2 类 | 21 CFR 878.4494 | 9 |
| NXF | Gas, Laser Generating | 第 1 类 | 21 CFR 878.4810 | |
| NYS | Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac) | 第 2 类 | 21 CFR 878.4015 | 1 |
| NYT | Prosthesis, Tracheal, Expandable, Polymeric | 第 2 类 | 21 CFR 878.3720 | 3 |
| NZP | Sealant, Microbial | 第 2 类 | 21 CFR 878.4370 | 4 |
| OAB | Low Energy Direct Current Thermal Ablation System | 第 2 类 | 21 CFR 878.4400 | 15 |
| OAJ | Catheter, Drainage, Intraoral/Extraoral | 第 1 类 | 21 CFR 878.4200 | 1 |
| OCL | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, | 第 2 类 | 21 CFR 878.4400 | 54 |
| ODR | Electrosurgical Patient Return Electrode | 第 2 类 | 21 CFR 878.4400 | 3 |
| ODU | Facial Implant | 第 2 类 | 21 CFR 878.3500 | 1 |
| OEA | Non-Surgical Gown | 第 1 类 | 21 CFR 878.4040 | |
| OEI | Drainage Catheter With Antibiotic | 第 2 类 | 21 CFR 878.4780 | 1 |
| OEL | Laser, Benign Prostatic Hyperplasia | 第 2 类 | 21 CFR 878.4810 | |
| OHO | First Aid Kit Without Drug | 第 1 类 | 21 CFR 878.4014 | |
| OHS | Light Based Over The Counter Wrinkle Reduction | 第 2 类 | 21 CFR 878.4810 | 162 |
| OHT | Light Based Over-The-Counter Hair Removal | 第 2 类 | 21 CFR 878.4810 | 163 |
| OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | 第 2 类 | 21 CFR 878.4590 | 30 |
| OJH | Orthopedic Tray | 第 1 类 | 21 CFR 878.4800 | |
| OJJ | Burn Kit Without Drug | 第 1 类 | 21 CFR 878.4022 | |
| OJR | Vacuum Powered Body Fluid Collection Kit | 第 2 类 | 21 CFR 878.4780 | |
| OJS | Tourniquet Kit | 第 1 类 | 21 CFR 878.5900 | |
| OJT | Aspiration Tray | 第 1 类 | 21 CFR 878.4800 | |
| OJU | Skin Prep Tray | 第 1 类 | 21 CFR 878.4800 | 1 |
| OJV | Single Use Instrument Tray | 第 1 类 | 21 CFR 878.4800 | |
| OJW | Shave Prep Kit | 第 2 类 | 21 CFR 878.4370 | |
| OKF | Body Fluid Disposal Kit | 第 2 类 | 21 CFR 878.4040 | |
| OKG | Body Fluid Clean Up Kit | 第 2 类 | 21 CFR 878.4040 | |
| OKH | Body Fluids Barrier Kit | 第 2 类 | 21 CFR 878.4040 | |
| OKI | Emergency Response Safety Kit | 第 2 类 | 21 CFR 878.4040 | |
| OKJ | Light Based Treatment For Cold Sores Herpes Simplex Virus-1 | 第 2 类 | 21 CFR 878.4860 | 4 |
| OKO | Negative Pressure Wound Therapy Non-Powered Suction Apparatus | 第 2 类 | 21 CFR 878.4683 | 17 |
| OLC | Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White | 第 2 类 | 21 CFR 878.3300 | 3 |
| OLI | Fat Reducing Low Level Laser | 第 2 类 | 21 CFR 878.5400 | 33 |
| OLL | Septal Stapler/Absorbable Staples | 第 2 类 | 21 CFR 878.4750 | 1 |
| OLP | Over-The-Counter Powered Light Based Laser For Acne | 第 2 类 | 21 CFR 878.4810 | 51 |
| OMD | Cutaneous Tissue Adhesive With Mesh | 第 2 类 | 21 CFR 878.4011 | 9 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 第 2 类 | 21 CFR 878.4780 | 214 |
| OMT | Absorbable Lung Biopsy Plug | 第 2 类 | 21 CFR 878.4755 | 2 |
| ONE | Powered Light Based Non-Laser Surgical Instrument | 第 2 类 | 21 CFR 878.4810 | 7 |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 第 2 类 | 21 CFR 878.4810 | 74 |
| ONG | Powered Laser Surgical Instrument With MicrobeamFractional Output | 第 2 类 | 21 CFR 878.4810 | 35 |
| ONO | Neurosurgical Laser With Mr Thermography | 第 2 类 | 21 CFR 878.4810 | 7 |
| ONQ | Electrosurgical Coagulation For Aesthetic | 第 2 类 | 21 CFR 878.4400 | 4 |
| ONT | N95 Respirator With Antimicrobial/Antiviral Agent | 第 2 类 | 21 CFR 878.4040 | 6 |
| ONV | Electrical Impedance Spectrometer | 第 2 类 | 21 CFR 878.1820 | |
| OOD | Surgical Film | 第 2 类 | 21 CFR 878.3300 | 13 |
| OOK | Dermal Cooling Pack/Vacuum/Massager | 第 2 类 | 21 CFR 878.4340 | 14 |
| OQL | Mesh, Surgical, Deployment Balloon | 第 2 类 | 21 CFR 878.3300 | 1 |
| ORC | Air Filter Portable Apparatus | 第 2 类 | 21 CFR 878.5070 | 6 |
| ORK | Laser Assisted Lipolysis | 第 2 类 | 21 CFR 878.4810 | 1 |
| ORQ | Mesh, Surgical, Deployer | 第 2 类 | 21 CFR 878.3300 | 6 |