| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| OTK | Wound Drain Catheter System | 第 2 类 | 21 CFR 878.4780 | 7 |
| OTM | Mesh, Surgical, For Stress Urinary Incontinence, Male | 第 2 类 | 21 CFR 878.3300 | 12 |
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontin | 第 2 类 | 21 CFR 878.3300 | 65 |
| OTO | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uter | 第 2 类 | 21 CFR 878.3300 | 23 |
| OUB | Instrument For Treatment Of Hyperhidrosis | 第 2 类 | 21 CFR 878.4400 | 3 |
| OUH | Skin Resurfacing Rf Applicator | 第 2 类 | 21 CFR 878.4400 | 5 |
| OUK | Surgical Mask With Antimicrobial/Antiviral Agent | 第 2 类 | 21 CFR 878.4040 | 4 |
| OUP | Powered Surgical Instrument For Improvement In The Appearance Of Cellu | 第 2 类 | 21 CFR 878.4790 | 9 |
| OVN | Suture Kit | 第 2 类 | 21 CFR 878.4830 | |
| OVR | Kit, First Aid, Talking | 第 1 类 | 21 CFR 878.4014 | 1 |
| OWR | Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery | 第 2 类 | 21 CFR 878.3300 | 1 |
| OWS | Mesh, Surgical, Collagen, Plastics, Facial Implants | 第 2 类 | 21 CFR 878.3300 | |
| OWT | Mesh, Surgical, Absorbable, Abdominal Hernia | 第 2 类 | 21 CFR 878.3300 | 11 |
| OWU | Mesh, Surgical, Non-Absorbable, Diaphragmatic Hernia | 第 2 类 | 21 CFR 878.3300 | |
| OWV | Mesh, Surgical, Collagen, Diaphragmatic Hernia | 第 2 类 | 21 CFR 878.3300 | 1 |
| OWW | Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon | 第 2 类 | 21 CFR 878.3300 | 10 |
| OWX | Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon | 第 2 类 | 21 CFR 878.3300 | 5 |
| OWY | Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | 第 2 类 | 21 CFR 878.3300 | 14 |
| OWZ | Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction | 第 2 类 | 21 CFR 878.3300 | |
| OXA | Mesh, Surgical, Non-Absorbable, Thoracic, Chest Wall Reconstruction | 第 2 类 | 21 CFR 878.3300 | |
| OXB | Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction | 第 2 类 | 21 CFR 878.3300 | |
| OXC | Mesh, Surgical, Absorbable, Staple Line Reinforcement | 第 2 类 | 21 CFR 878.3300 | 9 |
| OXD | Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement | 第 2 类 | 21 CFR 878.3300 | 3 |
| OXE | Mesh, Surgical, Collagen, Staple Line Reinforcement | 第 2 类 | 21 CFR 878.3300 | 4 |
| OXF | Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery | 第 2 类 | 21 CFR 878.3300 | 8 |
| OXG | Mesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery | 第 2 类 | 21 CFR 878.3300 | |
| OXH | Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | 第 2 类 | 21 CFR 878.3300 | 5 |
| OXI | Mesh, Surgical, Absorbable, Large Abdominal Wall Defects | 第 2 类 | 21 CFR 878.3300 | |
| OXJ | Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects | 第 2 类 | 21 CFR 878.3300 | 2 |
| OXK | Mesh, Surgical, Collagen, Large Abdominal Wall Defects | 第 2 类 | 21 CFR 878.3300 | 2 |
| OXL | Mesh, Surgical, Absorbable, Organ Support | 第 2 类 | 21 CFR 878.3300 | |
| OXM | Mesh, Surgical, Absorbable, Fistula | 第 2 类 | 21 CFR 878.3300 | |
| OXN | Mesh, Surgical, Collagen, Fistula | 第 2 类 | 21 CFR 878.3300 | 1 |
| OXT | Percutaneous Surgical Set With Attachments | 第 2 类 | 21 CFR 878.4805 | 1 |
| OXZ | Pediatric/Child Facemask | 第 2 类 | 21 CFR 878.4040 | 9 |
| OYD | Optical Diagnostic Device For Melanoma Detection | 第 2 类 | 21 CFR 878.1820 | |
| OYW | Laser, Cellulite Appearance | 第 2 类 | 21 CFR 878.4810 | 2 |
| PAG | Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Inco | 第 2 类 | 21 CFR 878.3300 | 9 |
| PAH | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontin | 第 2 类 | 21 CFR 878.3300 | 20 |
| PAJ | Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And | 第 2 类 | 21 CFR 878.3300 | 2 |
| PAY | Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reducti | 第 2 类 | 21 CFR 878.4420 | 12 |
| PBD | Composite Cultured Skin | 第 F 类 | 21 CFR 878.4024 | |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 第 2 类 | 21 CFR 878.4400 | 79 |
| PBY | Temporary Tissue Marker | 第 2 类 | 21 CFR 878.4300 | 7 |
| PDG | Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator. | 第 2 类 | 21 CFR 878.4400 | 1 |
| PDW | Internal Tissue Marker | 第 2 类 | 21 CFR 878.4670 | 3 |
| PDZ | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomyc | 第 2 类 | 21 CFR 878.4810 | 19 |
| PEM | Dental Barriers And Sleeves | 第 2 类 | 21 CFR 878.4370 | 15 |
| PFP | Silicone Hydrogel For Scar Management | 第 1 类 | 21 CFR 878.4025 | 1 |
| PGZ | Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal U | 第 2 类 | 21 CFR 878.4452 | 7 |
| PIJ | Collagen Surgical Mesh Containing Drugs | 第 2 类 | 21 CFR 878.3300 | 3 |
| PIR | Mercy Tape 2d And 3d Models | 第 1 类 | 21 CFR 878.4800 | 2 |
| PJK | Tissue Adhesive For Internal Use | 第 3 类 | 21 CFR 878.4010 | |
| PKD | Laceration Tray | 第 1 类 | 21 CFR 878.4014 | |
| PKE | Laparoscopic Cholecystectomy Kit | 第 1 类 | 21 CFR 878.4800 | |
| PKO | Transparent Patch For Use In Treatment Of Tattoos | 第 2 类 | 21 CFR 878.4810 | 2 |
| PKT | Laser For Disruption Of Adipocyte Cells For Aesthetic Use | 第 2 类 | 21 CFR 878.5400 | 19 |
| PLJ | Tissue Adhesive Internal Use | 第 3 类 | 21 CFR 878.4010 | |
| PLY | Antimicrobial Drapes | 第 2 类 | 21 CFR 878.4370 | |
| PMC | Scalp Cooling System | 第 2 类 | 21 CFR 878.4360 | 7 |
| PMX | Absorbable Collagen Hemostatic Agent With Thrombin | 第 3 类 | 21 CFR 878.4490 | |
| PNL | Magnetic Surgical System | 第 2 类 | 21 CFR 878.4815 | 8 |
| POD | Temporary, Internal Use Hemostatic | 第 2 类 | 21 CFR 878.4454 | 6 |
| PPP | Disposable Joint Aspiration/Injection Kit | 第 1 类 | 21 CFR 878.4800 | |
| PQI | Wound Retraction And Protection System | 第 2 类 | 21 CFR 878.4371 | 2 |
| PQM | Surgical Smoke Precipitator | 第 2 类 | 21 CFR 878.5050 | 7 |
| PQN | Carbon Dioxide Gas Controlled Tissue Expander | 第 2 类 | 21 CFR 878.3510 | 3 |
| PSN | Light Based Imaging | 第 2 类 | 21 CFR 878.4580 | 10 |
| PTX | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, | 第 2 类 | 21 CFR 878.4495 | |
| PUI | Drape, Surgical, Exempt | 第 2 类 | 21 CFR 878.4370 | |
| PXN | Basic Set-Up Tray | 第 1 类 | 21 CFR 878.4800 | |
| PXO | Bone Marrow Biopsy Tray | 第 1 类 | 21 CFR 878.4800 | |
| PXP | Breast Biopsy / Localization Tray | 第 1 类 | 21 CFR 878.4800 | |
| PXQ | Burn Dressing Tray | 第 1 类 | 21 CFR 878.4022 | |
| PXR | Cement And Bone Removal Kit | 第 1 类 | 21 CFR 878.4820 | |
| PXS | Cholecystectomy Kit | 第 1 类 | 21 CFR 878.4800 | |
| PXU | Fluid Drainage Tray | 第 1 类 | 21 CFR 878.4200 | |
| PXV | General Purpose Instrument Tray | 第 1 类 | 21 CFR 878.4800 | |
| PXW | Herniorraphy Kit | 第 1 类 | 21 CFR 878.4800 | |
| PXX | Incision Tray | 第 1 类 | 21 CFR 878.4800 | |
| PXY | Irrigation Kit (Wounds) | 第 1 类 | 21 CFR 878.4014 | |
| PXZ | Laparascopic Sphincterotomy Kit | 第 1 类 | 21 CFR 878.4800 | |
| PYA | Liver Biopsy Kit | 第 1 类 | 21 CFR 878.4800 | |
| PYB | Minor Surgical Procedures Tray | 第 1 类 | 21 CFR 878.4800 | |
| PYC | Paracentesis Tray | 第 1 类 | 21 CFR 878.4200 | |
| PYD | Pelviscopy Kit | 第 1 类 | 21 CFR 878.4800 | |
| PYE | Staple Removal Kit | 第 1 类 | 21 CFR 878.4760 | 1 |
| PYF | Sterile Puncture Tray | 第 1 类 | 21 CFR 878.4800 | |
| PYG | Suction Catheter Kit | 第 1 类 | 21 CFR 878.4200 | |
| PYH | Surgical Retractor Kit | 第 1 类 | 21 CFR 878.4800 | |
| PYI | Thoracic Catheter Insertion Tray | 第 1 类 | 21 CFR 878.4200 | |
| PYJ | Ulcer Wound Tray | 第 1 类 | 21 CFR 878.4014 | |
| PYK | Venous Ulcer Kit | 第 1 类 | 21 CFR 878.4014 | |
| PYL | Wound Drainage Kit | 第 1 类 | 21 CFR 878.4014 | |
| PYU | Sponge, Eyelid Cleaning, Powered | 第 1 类 | 21 CFR 878.4820 | |
| PZL | Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers | 第 2 类 | 21 CFR 878.4685 | 8 |
| PZP | Fluid Jet Removal System | 第 2 类 | 21 CFR 876.4350 | 9 |
| PZQ | General Laparoscopic Power Morcellation Containment System | 第 2 类 | 21 CFR 878.4825 | 1 |
| PZX | Left Atrial Appendage Clip, Implantable | 第 2 类 | 21 CFR 878.4300 | 10 |
| QAI | Powered Microneedle Device | 第 2 类 | 21 CFR 878.4430 | 26 |
| QAU | Hemostatic Device For Endoscopic Gastrointestinal Use | 第 2 类 | 21 CFR 878.4456 | 12 |
| QBW | Surgical Apparel With Material Claims | 第 2 类 | 21 CFR 878.4040 | 1 |
| QCR | Wound Autofluorescence Imaging Device | 第 1 类 | 21 CFR 878.4165 | 1 |
| QCY | Laser Absorbing Particles | 第 2 类 | 21 CFR 878.4810 | 2 |
| QDF | Parathyroid Autofluorescence Detection Device | 第 2 类 | 21 CFR 878.4550 | 1 |
| QDG | Parathyroid Autofluorescence Imaging Device | 第 2 类 | 21 CFR 878.4550 | 6 |
| QFC | Negative Pressure Wound Therapy Device For Reduction Of Wound Complica | 第 2 类 | 21 CFR 878.4783 | 3 |
| QGI | Air-Handling Apparatus Accessory | 第 1 类 | 21 CFR 878.5080 | |
| QGM | Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation | 第 2 类 | 21 CFR 878.4405 | 3 |
| QGX | General Use Pneumatic Tourniquet | 第 1 类 | 21 CFR 878.5910 | |
| QHF | Energy Based Device For Treatment Of Tattoos | 第 2 类 | 21 CFR 878.4810 | |
| QJF | Autofluorescence Imaging Adjunct Tool For Wounds | 第 2 类 | 21 CFR 878.4550 | 7 |
| QKL | Lipoaspirate Washing System For Aesthetic Body Contouring | 第 2 类 | 21 CFR 878.5040 | |
| QML | Anal Fistula Closure Device | 第 2 类 | 21 CFR 878.4835 | 1 |
| QMX | Label Or Tag, Non-Sterile | 第 1 类 | 21 CFR 878.4800 | |
| QNM | Mountable Electromechanical Surgical System For Transluminal Approache | 第 2 类 | 21 CFR 878.4961 | 8 |
| QPB | System, Suction, Lipoplasty For Removal | 第 2 类 | 21 CFR 878.5040 | 59 |
| QPC | Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High | 第 2 类 | 21 CFR 878.4040 | 11 |
| QPE | Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical | 第 2 类 | 21 CFR 878.4880 | 1 |
| QPX | Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical | 第 2 类 | 21 CFR 878.4683 | 1 |
| QPZ | Contact Cooling For Skin Lesion Pain Relief | 第 2 类 | 21 CFR 878.4340 | 2 |
| QQO | Cranial Measurement Software | 第 1 类 | 21 CFR 878.4800 | 1 |
| QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevent | 第 2 类 | 21 CFR 878.4850 | 17 |
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | 第 2 类 | 21 CFR 878.4850 | 27 |
| QRM | Multiple Use Blood Lancet For Multiple Patient Use | 第 3 类 | 21 CFR 878.4850 | |
| QSO | Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With | 第 2 类 | 21 CFR 878.4040 | |
| QUB | Suction Lipoplasty System For Removal And Transfer | 第 2 类 | 21 CFR 878.5040 | |
| QUQ | Knife, Intraocular Pressure Lowering | 第 2 类 | 21 CFR 878.4400 | 1 |
| QUW | Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament | 第 2 类 | 21 CFR 878.3300 | 5 |
| QVJ | Low Power Electrosurgical Devices For Skin Lesion Destruction | 第 2 类 | 21 CFR 878.4400 | 4 |
| QVS | Breast Implant Suction Retrieval Device | 第 2 类 | 21 CFR 878.4675 | 2 |
| QVX | Skin Patch For Treatment Of Hyperhidrosis | 第 2 类 | 21 CFR 878.4425 | 1 |
| QWJ | Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of L | 第 2 类 | 21 CFR 878.3300 | 1 |
| QXW | Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer | 第 2 类 | 21 CFR 878.4355 | 1 |
| QYK | Semi-Automated Autologous Skin Graft Harvesting And Application Device | 第 2 类 | 21 CFR 878.4795 | 1 |
| QZN | Multi-Photon Imaging | 第 2 类 | 21 CFR 878.4580 | 1 |
| QZS | Software-Aided Adjunctive Diagnostic Device For Use By Physicians On L | 第 2 类 | 21 CFR 878.1830 | 1 |
| RAB | Sunlamp Products (Pre-Standard) | 第 2 类 | 21 CFR 878.4635 | |
| REF | Suntan Bed | 第 2 类 | 21 CFR 878.4635 | |
| REG | Suntan Lamp | 第 2 类 | 21 CFR 878.4635 | |
| REH | Tabletop Sunlamp System | 第 2 类 | 21 CFR 878.4635 | |
| SAB | Table Mounted Miniaturized Electromechanical Surgical System | 第 2 类 | 21 CFR 878.4962 | 2 |
| SAH | Magnetic Compression Anastomosis System | 第 2 类 | 21 CFR 878.4816 | 8 |
| SAM | Battery-Powered Instruments Charged Through Sterile Barriers | 第 1 类 | 21 CFR 878.4820 | 1 |
| SAQ | Electromechanical System For Open Microsurgery | 第 2 类 | 21 CFR 878.4963 | 5 |
| SCV | Modular Electromechanical Surgical System | 第 2 类 | 21 CFR 878.4964 | 4 |
| SDD | Electromechanical Surgical System Wherein The Surgeon Annd The User In | 第 2 类 | 21 CFR 878.4965 | 5 |
| SFG | Camera, Surgical, Measurement | 第 1 类 | 21 CFR 878.4160 | 1 |
| SFQ | Electrosurgical, Cutting & Coagulation & Accessories, For Cardiac Elec | 第 2 类 | 21 CFR 878.4400 | |
| SGV | Agent, Absorbable Hemostatic, Collagen With Polymeric Additives | 第 3 类 | 21 CFR 878.4490 | |
| SGZ | Ultraviolet Lamp Products | 第 2 类 | 21 CFR 878.4635 | 1 |
| SHA | Solid Wound Dressing With Permanently Bound Antimicrobial Agent | 第 2 类 | 21 CFR 878.4013 | 1 |
| SHY | Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Prov | 第 2 类 | 21 CFR 878.1840 | 1 |
| SIR | Integrated Operating Table-Electromechanical Surgical System | 第 2 类 | 21 CFR 878.4966 | 1 |