| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| OIG | Powder-Free Guayle Rubber Examination Glove | 第 1 类 | 21 CFR 880.6250 | 1 |
| OJA | Intravenous Extension Tubing Set | 第 2 类 | 21 CFR 880.5440 | 1 |
| OKC | Implanted Subcutaneous Securement Catheter | 第 2 类 | 21 CFR 880.5970 | 5 |
| OKE | Port Introducer Kit | 第 2 类 | 21 CFR 880.5965 | |
| OKL | Intravascular Administration Set, Automated Air Removal System | 第 2 类 | 21 CFR 880.5445 | 2 |
| OMF | Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory Fo | 第 2 类 | 21 CFR 880.5970 | 2 |
| ONB | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer S | 第 2 类 | 21 CFR 880.5440 | 41 |
| ONK | Oral Lubricant | 第 1 类 | 21 CFR 880.6375 | 1 |
| ONM | Radiant Infant Warmer Cabinet | 第 2 类 | 21 CFR 880.5130 | |
| OPC | Powder-Free Polychloroprene Patient Examination Glove | 第 1 类 | 21 CFR 880.6250 | 1 |
| OPH | Radiation Attenuating Medical Glove | 第 1 类 | 21 CFR 880.6250 | |
| OPJ | Medical Gloves With Chemotherapy Labeling Claims - Test For Use With C | 第 1 类 | 21 CFR 880.6250 | |
| OPP | Pump, Infusion, Insulin Bolus | 第 2 类 | 21 CFR 880.5725 | 7 |
| ORW | N95 Respirator With Antimicrobial/Antiviral Agent For Use By The Gener | 第 2 类 | 21 CFR 880.6260 | 1 |
| OSI | Bariatric Bed | 第 2 类 | 21 CFR 880.5100 | |
| OSZ | Antimicrobial Keyboard | 第 2 类 | 21 CFR 880.6600 | 1 |
| OUG | Medical Device Data System | 第 1 类 | 21 CFR 880.6310 | 1 |
| OUW | Infant Positioner, Rx, Use In Highly Monitored Setting | 第 1 类 | 21 CFR 880.5680 | 1 |
| OVY | Liquid Chemical Processing System | 第 2 类 | 21 CFR 880.6887 | 4 |
| OWL | Peripheral Catheter Insertion Kit | 第 2 类 | 21 CFR 880.5200 | |
| OWP | Biological Sterilization Process Indicator With Recombinant-Dna Plasmi | 第 2 类 | 21 CFR 880.2805 | 5 |
| OXQ | Dressing Change Tray | 第 1 类 | 21 CFR 880.5075 | |
| OYS | Patient Bed With Canopy/Restraints | 第 1 类 | 21 CFR 880.6760 | 3 |
| OZK | Thermometer, Exhaled Breath | 第 2 类 | 21 CFR 880.2910 | |
| OZW | Ingestible Event Marker | 第 2 类 | 21 CFR 880.6305 | 8 |
| PAD | Chest Drainage Kit | 第 2 类 | 21 CFR 880.6740 | |
| PBZ | Image Processing Device For Estimation Of External Blood Loss | 第 2 类 | 21 CFR 880.2750 | 6 |
| PDH | Blanket, Neonatal Phototherapy | 第 2 类 | 21 CFR 880.5700 | 2 |
| PEC | Sterilizer Automated Loading System | 第 2 类 | 21 CFR 880.6880 | 1 |
| PEF | Heparin Flush In 0.45% Sodium Chloride | 第 2 类 | 21 CFR 880.5200 | |
| PEQ | Accessories To Examination Light | 第 1 类 | 21 CFR 880.6320 | 1 |
| PEZ | Central Venous Catheter Dressing Change Kit | 第 2 类 | 21 CFR 880.5200 | |
| PHC | Infusion Safety Management Software | 第 2 类 | 21 CFR 880.5725 | 10 |
| PJJ | Two Or More Sterilant Sterilizer | 第 2 类 | 21 CFR 880.6860 | 6 |
| PJO | Fall Prevention Alarm/Sensor Combination Attached Or Unattached | 第 1 类 | 21 CFR 880.2400 | |
| PJP | Fall Prevention Alarm/Sensor Attached Only | 第 1 类 | 21 CFR 880.2400 | |
| PKP | Immunoglobulin G (Igg) Infusion System | 第 2 类 | 21 CFR 880.5725 | 7 |
| PMS | Peripheral Intravenous (Piv) Infiltration Monitor | 第 2 类 | 21 CFR 880.5725 | 5 |
| PND | Midline Catheter | 第 2 类 | 21 CFR 880.5200 | 13 |
| POQ | Blood Transfusion Kit | 第 2 类 | 21 CFR 880.5440 | |
| POR | Parenteral Administration Kit | 第 2 类 | 21 CFR 880.5440 | |
| PQH | Iodinated Contrast Media Transfer Tubing Set | 第 2 类 | 21 CFR 880.5440 | 6 |
| PQX | Epinephrine Syringe | 第 2 类 | 21 CFR 880.5860 | 2 |
| PRN | Pediatric Position Holder | 第 1 类 | 21 CFR 880.5680 | |
| PTD | Subcutaneous Implanted Apheresis Port | 第 2 类 | 21 CFR 880.5965 | 3 |
| PTI | Non-Coring (Huber) Needle | 第 2 类 | 21 CFR 880.5570 | 13 |
| PUK | Administration Set Securement Device | 第 1 类 | 21 CFR 880.5210 | |
| PUN | Lice Removal Kit Containing A Solution | 第 1 类 | 21 CFR 880.5960 | |
| PUR | Vacuum Syringe | 第 2 类 | 21 CFR 880.5860 | 2 |
| PVZ | Non-Stainless Steel Needle | 第 2 类 | 21 CFR 880.5570 | 1 |
| PWH | Administrations Sets With Neuraxial Connectors | 第 2 类 | 21 CFR 880.5440 | 4 |
| PWM | Admission Kit (Patient Utensil) | 第 1 类 | 21 CFR 880.6730 | |
| PWN | Baby Care Kit | 第 2 类 | 21 CFR 880.5700 | |
| PWO | Blood Administration Kit | 第 2 类 | 21 CFR 880.5440 | |
| PWP | Blood Borne Pathogen Response Kit | 第 1 类 | 21 CFR 880.6250 | |
| PWQ | Buret Administration Intravenous Kit | 第 2 类 | 21 CFR 880.5440 | |
| PWR | Catheter Repair Kit | 第 2 类 | 21 CFR 880.5970 | |
| PWS | Chemotherapy Administration Kit | 第 1 类 | 21 CFR 880.6250 | |
| PWT | Chemotherapy Spill Clean-Up Kit | 第 1 类 | 21 CFR 880.6250 | |
| PWU | Clean-Up Kit | 第 1 类 | 21 CFR 880.6890 | |
| PWV | Delivery Room Apparel Kit | 第 1 类 | 21 CFR 880.6250 | |
| PWW | Fever Monitoring Kit | 第 2 类 | 21 CFR 880.2910 | |
| PWX | Insect Sting Emergency Kit | 第 1 类 | 21 CFR 880.5740 | |
| PWY | Lumbar Puncture Tray (Adult & Pediatric) | 第 2 类 | 21 CFR 880.5570 | |
| PWZ | Mid-Stream Collection Kit | 第 1 类 | 21 CFR 880.6730 | |
| PXA | Oral Administration Set | 第 1 类 | 21 CFR 880.6430 | |
| PXB | Percutaneous Introducer Kit | 第 2 类 | 21 CFR 880.5570 | |
| PXC | Personal Protection Kit | 第 1 类 | 21 CFR 880.6250 | |
| PXD | Prep Kit | 第 1 类 | 21 CFR 880.6250 | |
| PXF | Sitz Bath Kit | 第 1 类 | 21 CFR 880.6730 | |
| PXG | Spill Kit | 第 1 类 | 21 CFR 880.6890 | |
| PXH | Thermometer Kit | 第 2 类 | 21 CFR 880.2910 | |
| PXI | Thoracentesis Tray | 第 2 类 | 21 CFR 880.5570 | |
| PXJ | Umbilical Catheter Insertion Tray | 第 2 类 | 21 CFR 880.5200 | |
| PXK | Vascular Access Port Kit | 第 2 类 | 21 CFR 880.5965 | |
| PXL | Venipuncture Kit | 第 2 类 | 21 CFR 880.5570 | |
| PXM | Vomitus Clean-Up Kit | 第 1 类 | 21 CFR 880.6890 | |
| PYO | Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use | 第 1 类 | 21 CFR 880.5240 | 1 |
| PYQ | Rfid Chip For Dental Appliance | 第 2 类 | 21 CFR 880.6300 | 1 |
| PYR | Neuraxial Administration Set - Intrathecal Delivery | 第 2 类 | 21 CFR 880.5440 | |
| PZW | Catheter Access Cover, Tamper-Resistant | 第 2 类 | 21 CFR 880.5970 | 2 |
| QBL | Piston Syringe Lever | 第 2 类 | 21 CFR 880.5860 | 3 |
| QBP | Cap, Device Disinfectant | 第 2 类 | 21 CFR 880.5440 | 22 |
| QDM | Midazolam Syringe | 第 2 类 | 21 CFR 880.5860 | |
| QDO | Fentanyl And Other Opioid Protection Glove | 第 1 类 | 21 CFR 880.6250 | |
| QEH | Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or | 第 2 类 | 21 CFR 880.5860 | 5 |
| QFB | Isocapnic Ventilation Device | 第 2 类 | 21 CFR 868.5480 | 1 |
| QJT | Rigid Sterilization Container With Software | 第 2 类 | 21 CFR 880.6855 | 1 |
| QJY | Infusion Pump, Drug Specific, Pharmacy-Filled | 第 2 类 | 21 CFR 880.5725 | 4 |
| QKM | A Chemical Vapor Sterilization Multivariable Chemical Indicator | 第 2 类 | 21 CFR 880.2800 | 5 |
| QLF | On-Body Injector | 第 2 类 | 21 CFR 880.5860 | |
| QLY | Ophthalmic Syringe | 第 2 类 | 21 CFR 880.5860 | 7 |
| QMT | Prep Kit Vaccine Injection | 第 2 类 | 21 CFR 880.5570 | |
| QNQ | Low Dead Space Piston Syringe | 第 2 类 | 21 CFR 880.5860 | 12 |
| QNS | Low Dead Space Needle, Single Lumen, Hypodermic | 第 2 类 | 21 CFR 880.5570 | 3 |
| QOG | Injection Data Capture Device | 第 2 类 | 21 CFR 880.5860 | 7 |
| QOI | Intravenous Catheter Force-Activated Separation Device. | 第 2 类 | 21 CFR 880.5220 | 8 |
| QQS | Stapler, Skin | 第 1 类 | 21 CFR 878.4740 | |
| QTG | Infant Supine Sleep System | 第 2 类 | 21 CFR 880.5690 | 1 |
| QTI | Saline Vascular Access Flush With Integrated Alcohol Disinfectant Devi | 第 2 类 | 21 CFR 880.5200 | 1 |
| QTV | Mattress And Bed Deck Cover (Medical Purposes) | 第 1 类 | 21 CFR 880.6190 | 1 |
| QVB | Biological Sterilization Indicator With Indirect Growth Detection | 第 2 类 | 21 CFR 880.2806 | 3 |
| QVY | Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinen | 第 2 类 | 21 CFR 880.5151 | 1 |
| QWS | Foam Or Gel Chemical Sterilant/High Level Disinfectant | 第 2 类 | 21 CFR 880.6886 | 2 |
| QWX | Active Noise Attenuation System For Infant Incubators | 第 2 类 | 21 CFR 880.5405 | 1 |
| QXC | Diabetes Digital Therapeutic Device | 第 2 类 | 21 CFR 880.5735 | 1 |
| QXJ | Whole Room Microbial Reduction Device | 第 2 类 | 21 CFR 880.6510 | 2 |
| QXQ | Respiratory Accessory Microbial Reduction Device. | 第 2 类 | 21 CFR 880.6993 | 3 |
| QYM | Ophthalmic Needle | 第 2 类 | 21 CFR 880.5570 | 2 |
| QZA | Body Temperature Sensing Software | 第 2 类 | 21 CFR 880.2915 | 2 |
| SAK | Software Device To Aid In The Prediction Or Diagnosis Of Sepsis | 第 2 类 | 21 CFR 880.6316 | 2 |
| SBE | Digital Physical/Chemical Sterilization Process Sensor | 第 2 类 | 21 CFR 880.2801 | 1 |
| SBO | Bed-Patient Activity Monitoring System | 第 1 类 | 21 CFR 880.2400 | 1 |
| SCL | Allergen And Vaccine Delivery Needles | 第 2 类 | 21 CFR 880.5570 | 25 |
| SCS | Ultraviolet Radiation Disinfection Chamber Device | 第 2 类 | 21 CFR 880.6511 | 2 |
| SDC | Qualitative Cleaning Process Protein Indicator | 第 2 类 | 21 CFR 880.6930 | 1 |
| SDV | Clinical Electronic Thermometer | 第 2 类 | 21 CFR 880.2910 | |
| SDW | Stationary Infrared Thermometer | 第 2 类 | 21 CFR 880.2910 | |
| SEF | Central Venous Catheter With Manual Insertion System | 第 2 类 | 21 CFR 880.5200 | 1 |
| SEW | Automated Endoscope Channel Cleaner | 第 2 类 | 21 CFR 880.6994 | 2 |
| SGX | Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated | 第 2 类 | 21 CFR 880.6512 | 1 |
| SHM | Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe | 第 2 类 | 21 CFR 880.6891 | 1 |