| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| FHG | Bell, Circumcision | 第 2 类 | 21 CFR 884.4530 | 2 |
| FHJ | Shield, Circumcision | 第 2 类 | 21 CFR 884.4530 | 2 |
| HCY | Curette, Uterine | 第 1 类 | 21 CFR 884.4530 | 11 |
| HCZ | Forceps, Surgical, Gynecological | 第 2 类 | 21 CFR 884.4530 | 24 |
| HDA | Forceps, Obstetrical | 第 2 类 | 21 CFR 884.4400 | 10 |
| HDB | Extractor, Vacuum, Fetal | 第 2 类 | 21 CFR 884.4340 | 30 |
| HDC | Tenaculum, Uterine | 第 2 类 | 21 CFR 884.4530 | 20 |
| HDD | Table, Obstetrical, Ac-Powered (And Accessories) | 第 2 类 | 21 CFR 884.4900 | 7 |
| HDE | Hook, Fibroid, Gynecological | 第 1 类 | 21 CFR 884.4520 | |
| HDF | Speculum, Vaginal, Metal | 第 1 类 | 21 CFR 884.4520 | 11 |
| HDG | Speculum, Vaginal, Metal, Fiberoptic | 第 1 类 | 21 CFR 884.4520 | 2 |
| HDH | Needle, Cerclage, Gynecological | 第 1 类 | 21 CFR 884.4530 | |
| HDI | Hook, Destructive, Obstetrical | 第 2 类 | 21 CFR 884.4500 | |
| HDJ | Scissors, Umbilical | 第 1 类 | 21 CFR 884.4520 | 1 |
| HDK | Scissors, Episiotomy | 第 1 类 | 21 CFR 884.4520 | |
| HDL | Retractor, Vaginal | 第 1 类 | 21 CFR 884.4520 | 2 |
| HDM | Packer, Uterine | 第 1 类 | 21 CFR 884.4520 | |
| HDN | Dilator, Cervical, Expandable | 第 3 类 | 21 CFR 884.4250 | |
| HDO | Valve, Tubal Occlusion | 第 3 类 | 21 CFR 884.5380 | |
| HDP | Elevator, Uterine | 第 2 类 | 21 CFR 884.4530 | 4 |
| HDQ | Dilator, Cervical, Fixed Size | 第 1 类 | 21 CFR 884.4530 | 6 |
| HDR | Cap, Cervical | 第 2 类 | 21 CFR 884.5250 | 29 |
| HDT | Device, Intrauterine, Contraceptive And Introducer | 第 3 类 | 21 CFR 884.5360 | |
| HDW | Diaphragm, Contraceptive (And Accessories) | 第 2 类 | 21 CFR 884.5350 | 4 |
| HDX | Dilator, Vaginal | 第 2 类 | 21 CFR 884.3900 | 9 |
| HDY | Dilator, Cervical, Hygroscopic-Laminaria | 第 2 类 | 21 CFR 884.4260 | 11 |
| HDZ | Knife, Cervical Cone | 第 2 类 | 21 CFR 884.4530 | |
| HEB | Tampon, Menstrual, Unscented | 第 2 类 | 21 CFR 884.5470 | 189 |
| HEC | Insufflator, Vaginal | 第 1 类 | 21 CFR 884.5920 | |
| HED | Douche Apparatus, Vaginal, Therapeutic | 第 1 类 | 21 CFR 884.5900 | 12 |
| HEE | Set, Anesthesia, Paracervical | 第 2 类 | 21 CFR 884.5100 | 9 |
| HEG | Set, Anesthesia, Pudendal | 第 2 类 | 21 CFR 884.5100 | |
| HEH | Chamber, Decompression, Abdominal | 第 3 类 | 21 CFR 884.5225 | |
| HEI | Monitor, Heart-Valve Movement, Fetal, Ultrasonic | 第 2 类 | 21 CFR 884.2660 | 3 |
| HEJ | Monitor, Hemic Sound, Ultrasonic | 第 2 类 | 21 CFR 884.2660 | |
| HEK | Monitor, Heart Sound, Fetal, Ultrasonic | 第 2 类 | 21 CFR 884.2660 | 5 |
| HEL | Monitor, Heart Rate, Fetal, Ultrasonic | 第 2 类 | 21 CFR 884.2660 | 7 |
| HEM | Imager, Ultrasonic Obstetric-Gynecologic | 第 2 类 | 21 CFR 884.2225 | 30 |
| HEN | Caliper, Fetal Head, Ultrasonic | 第 2 类 | 21 CFR 884.2225 | |
| HEO | Analyzer, Data, Obstetric | 第 3 类 | 21 CFR 884.2050 | |
| HEP | Monitor, Blood-Flow, Ultrasonic | 第 2 类 | 21 CFR 884.2660 | 4 |
| HEQ | Monitor, Pressure, Arterial, Fetal, Ultrasonic | 第 2 类 | 21 CFR 884.2660 | |
| HER | Pelvimeter, External | 第 1 类 | 21 CFR 884.4520 | |
| HES | Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) | 第 2 类 | 21 CFR 884.1300 | 13 |
| HET | Laparoscope, Gynecologic (And Accessories) | 第 2 类 | 21 CFR 884.1720 | 338 |
| HEW | Culdoscope (And Accessories) | 第 2 类 | 21 CFR 884.1640 | 18 |
| HEX | Colposcope (And Colpomicroscope) | 第 2 类 | 21 CFR 884.1630 | 56 |
| HEZ | Endoscope, Transcervical (Amnioscope)(And Accessories) | 第 2 类 | 21 CFR 884.1660 | |
| HFA | Amnioscope, Transabdominal (Fetoscope) (And Accessories) | 第 F 类 | 21 CFR 884.1600 | |
| HFB | Forceps, Biopsy, Gynecological | 第 1 类 | 21 CFR 884.4530 | 22 |
| HFC | Aspirator, Endocervical | 第 2 类 | 21 CFR 884.1050 | 11 |
| HFD | Washer, Endometrial | 第 2 类 | 21 CFR 884.1185 | 3 |
| HFE | Brush, Endometrial | 第 2 类 | 21 CFR 884.1100 | 9 |
| HFF | Aspirator, Endometrial | 第 2 类 | 21 CFR 884.1060 | 5 |
| HFG | Coagulator, Laparoscopic, Unipolar (And Accessories) | 第 2 类 | 21 CFR 884.4160 | 11 |
| HFH | Coagulator, Hysteroscopic (And Accessories) | 第 2 类 | 21 CFR 884.4160 | |
| HFI | Coagulator, Culdoscopic (And Accessories) | 第 2 类 | 21 CFR 884.4160 | 8 |
| HFJ | Prosthesis, Fallopian Tube | 第 2 类 | 21 CFR 884.3650 | 1 |
| HFK | Mold, Vaginal | 第 2 类 | 21 CFR 884.3900 | 1 |
| HFL | Drain, Cervical | 第 2 类 | 21 CFR 884.3200 | 1 |
| HFM | Monitor, Uterine Contraction, External (For Use In Clinic) | 第 2 类 | 21 CFR 884.2720 | 23 |
| HFN | Transducer, Pressure, Intrauterine | 第 2 类 | 21 CFR 884.2700 | 9 |
| HFO | Recorder, Pressure, Intrauterine | 第 2 类 | 21 CFR 884.2700 | 4 |
| HFP | Monitor, Phonocardiographic, Fetal | 第 2 类 | 21 CFR 884.2640 | |
| HFW | Clamp, Umbilical | 第 2 类 | 21 CFR 884.4530 | 36 |
| HFX | Clamp, Circumcision | 第 2 类 | 21 CFR 884.4530 | 27 |
| HFY | Band, Tubal Occlusion | 第 3 类 | 21 CFR 884.5380 | |
| HFZ | Craniotribe | 第 2 类 | 21 CFR 884.4500 | |
| HGA | Cranioclast | 第 2 类 | 21 CFR 884.4500 | |
| HGB | Clip, Tubal Occlusion | 第 3 类 | 21 CFR 884.5380 | |
| HGC | Clamp, Uterine | 第 1 类 | 21 CFR 884.4520 | 2 |
| HGD | Applicator, Vaginal | 第 1 类 | 21 CFR 884.4520 | 1 |
| HGE | Amniotome | 第 1 类 | 21 CFR 884.4530 | 6 |
| HGF | Source, Abortion Unit, Vacuum | 第 2 类 | 21 CFR 884.5070 | 4 |
| HGG | Controller, Abortion Unit, Vacuum | 第 2 类 | 21 CFR 884.5070 | 1 |
| HGH | Cannula, Suction, Uterine | 第 2 类 | 21 CFR 884.5070 | 6 |
| HGI | Electrocautery, Gynecologic (And Accessories) | 第 2 类 | 21 CFR 884.4120 | 53 |
| HGK | Endoscope, Fetal Blood Sampling (And Accessories) | 第 2 类 | 21 CFR 884.1660 | 1 |
| HGL | Transducer, Ultrasonic, Obstetric | 第 2 类 | 21 CFR 884.2960 | 36 |
| HGM | System, Monitoring, Perinatal | 第 2 类 | 21 CFR 884.2740 | 215 |
| HGN | Stethoscope, Fetal | 第 1 类 | 21 CFR 884.2900 | 2 |
| HGO | Monitor, Electroencephalographic, Fetal (And Accessories) | 第 3 类 | 21 CFR 884.2620 | |
| HGP | Electrode, Circular (Spiral), Scalp And Applicator | 第 2 类 | 21 CFR 884.2675 | 17 |
| HGS | Catheter, Intrauterine And Introducer | 第 2 类 | 21 CFR 884.2700 | 2 |
| HGW | Sampler, Blood, Fetal | 第 2 类 | 21 CFR 884.1560 | 4 |
| HGX | Pump, Breast, Powered | 第 2 类 | 21 CFR 884.5160 | 250 |
| HGY | Pump, Breast, Non-Powered | 第 1 类 | 21 CFR 884.5150 | 27 |
| HGZ | Heater, Perineal, Direct Contact | 第 2 类 | 21 CFR 884.5390 | 1 |
| HHA | Heater, Perineal, Radiant, Non-Contact | 第 2 类 | 21 CFR 884.5390 | |
| HHD | Pad, Menstrual, Unscented | 第 1 类 | 21 CFR 884.5435 | 136 |
| HHE | Cup, Menstrual | 第 2 类 | 21 CFR 884.5400 | 16 |
| HHF | Remover, Intrauterine Device, Contraceptive, Hook-Type | 第 1 类 | 21 CFR 884.4530 | 6 |
| HHG | Dilator, Cervical, Vibratory | 第 3 类 | 21 CFR 884.4270 | |
| HHI | System, Abortion, Vacuum | 第 2 类 | 21 CFR 884.5070 | 24 |
| HHJ | Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic | 第 2 类 | 21 CFR 884.2225 | 1 |
| HHK | Curette, Suction, Endometrial (And Accessories) | 第 2 类 | 21 CFR 884.1175 | 42 |
| HHL | Pad, Menstrual, Scented, Scented-Deodorized | 第 2 类 | 21 CFR 884.5425 | 57 |
| HHM | Sound, Uterine | 第 1 类 | 21 CFR 884.4530 | 10 |
| HHN | Cleidoclast | 第 2 类 | 21 CFR 884.4500 | |
| HHO | Screw, Fibroid, Gynecological | 第 2 类 | 21 CFR 884.4530 | 2 |
| HHP | Table, Obstetrical, Manual (And Accessories) | 第 2 类 | 21 CFR 884.4900 | 2 |
| HHQ | System, Abortion, Metreurynter-Balloon | 第 3 类 | 21 CFR 884.5050 | |
| HHR | Laser, Surgical, Gynecologic | 第 2 类 | 21 CFR 884.4550 | 48 |
| HHS | Transcervical Contraceptive Tubal Occlusion Device | 第 3 类 | 21 CFR 884.5380 | |
| HHT | Spatula, Cervical, Cytological | 第 2 类 | 21 CFR 884.4530 | 73 |
| HHW | Pessary, Vaginal | 第 2 类 | 21 CFR 884.3575 | 41 |
| HHX | Holograph, Fetal, Acoustical | 第 2 类 | 21 CFR 884.2225 | |
| HIB | Speculum, Vaginal, Nonmetal | 第 2 类 | 21 CFR 884.4530 | 72 |
| HIC | Speculum, Vaginal, Nonmetal, Fiberoptic | 第 2 类 | 21 CFR 884.4530 | 5 |
| HIF | Insufflator, Laparoscopic | 第 2 类 | 21 CFR 884.1730 | 179 |
| HIG | Insufflator, Hysteroscopic | 第 2 类 | 21 CFR 884.1700 | 57 |
| HIH | Hysteroscope (And Accessories) | 第 2 类 | 21 CFR 884.1690 | 172 |
| HII | Stimulator, Vaginal, Muscle, Powered, For Therapeutic Use | 第 3 类 | 21 CFR 884.5940 | |
| HIL | Tampon, Menstrual, Scented, Scented-Deodorized | 第 2 类 | 21 CFR 884.5460 | 84 |
| HIM | Electrocautery, Endoscopic And Accessories | 第 2 类 | 21 CFR 884.4100 | |
| HIN | Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | 第 2 类 | 21 CFR 884.4150 | 16 |
| HIO | Sampler, Amniotic Fluid (Amniocentesis Tray) | 第 1 类 | 21 CFR 884.1550 | 20 |
| HIQ | Electrode, Clip, Fetal Scalp (And Applicator) | 第 3 类 | 21 CFR 884.2685 | |
| HIR | Perineometer | 第 2 类 | 21 CFR 884.1425 | 65 |
| HIS | Condom | 第 2 类 | 21 CFR 884.5300 | 401 |
| IYM | System, Telethermographic, Infrared | 第 3 类 | 21 CFR 884.2980 | 8 |
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | 第 2 类 | 21 CFR 884.4530 | 58 |
| KNB | Instrument, Destructive, Fetal, Obstetric | 第 2 类 | 21 CFR 884.4500 | 1 |
| KNC | Table, Obstetric (And Accessories) | 第 2 类 | 21 CFR 884.4900 | 26 |
| KND | Heater, Perineal | 第 2 类 | 21 CFR 884.5390 | |
| KNE | Set, Anesthesia, Obstetric | 第 2 类 | 21 CFR 884.5100 | 2 |
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | 第 2 类 | 21 CFR 884.4160 | 44 |
| KNG | Monitor, Ultrasonic, Fetal | 第 2 类 | 21 CFR 884.2660 | 60 |
| KNH | Laparoscopic Contraceptive Tubal Occlusion Device | 第 3 类 | 21 CFR 884.5380 | |
| KOH | Instrument, Manual, General Obstetric-Gynecologic | 第 1 类 | 21 CFR 884.4520 | 15 |
| KXN | Monitor, Cardiac, Fetal | 第 2 类 | 21 CFR 884.2600 | 2 |
| KXO | Monitor, Pressure, Intrauterine | 第 2 类 | 21 CFR 884.2700 | 26 |
| KXP | Stent, Vaginal | 第 2 类 | 21 CFR 884.3900 | 4 |
| KXQ | Vibrator For Therapeutic Use, Genital | 第 2 类 | 21 CFR 884.5960 | 4 |
| KXZ | System, Thermographic, Liquid Crystal, Powered (Adjunctive Use) | 第 3 类 | 21 CFR 884.2982 | 7 |
| KYA | System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use) | 第 1 类 | 21 CFR 884.2982 | 5 |
| LBX | Pelvimeter, Internal | 第 2 类 | 21 CFR 884.4530 | 1 |
| LHM | System, Thermographic, Liquid Crystal | 第 1 类 | 21 CFR 884.2982 | 1 |
| LHP | System, Telethermographic (Sole Diagnostic Screen) | 第 3 类 | 21 CFR 884.2980 | |
| LHQ | System, Telethermographic (Adjunctive Use) | 第 1 类 | 21 CFR 884.2980 | 41 |
| LHR | System, Thermographic, Liquid Crystal (Sole Diagnostic Screen) | 第 3 类 | 21 CFR 884.2982 | |
| LHZ | Viscometer, Mucus, Cervical | 第 1 类 | 21 CFR 884.1040 | 1 |
| LKF | Cannula, Manipulator/Injector, Uterine | 第 2 类 | 21 CFR 884.4530 | 87 |
| LLW | Laser, Neodymium:Yag For Gynecologic Use | 第 2 类 | 21 CFR 884.4550 | 1 |
| LQK | Home Uterine Activity Monitor | 第 2 类 | 21 CFR 884.2730 | 5 |
| LTZ | Condom With Nonoxynol-9 | 第 2 类 | 21 CFR 884.5310 | 22 |
| LXE | Doppler, Fetal, Ultrasound | 第 2 类 | 21 CFR 884.2660 | |
| LZL | Micro-Condom | 第 3 类 | 21 CFR 884.5320 | |
| MAA | Monitor, Fetal Doppler Ultrasound | 第 2 类 | 21 CFR 884.2660 | 9 |
| MBU | Single-Use Internal Condom | 第 2 类 | 21 CFR 884.5340 | |
| MDG | System, Intrafallopian Cannula | 第 2 类 | 21 CFR 884.4530 | 1 |
| MFD | Cannula, Intrauterine Insemination | 第 2 类 | 21 CFR 884.5250 | 29 |
| MKO | Falloposcope | 第 2 类 | 21 CFR 884.1690 | 4 |
| MLS | Labor And Delivery Kit | 第 2 类 | 21 CFR 884.4530 | 6 |
| MLT | Pelvic Exam Kit | 第 2 类 | 21 CFR 884.4530 | 1 |
| MOH | Monitor, Heart Rate, Fetal, Non-Stress Test (Home Use) | 第 2 类 | 21 CFR 884.2730 | |
| MOK | Vaginoscope And Accessories | 第 2 类 | 21 CFR 884.1630 | 2 |
| MOL | Condom, Synthetic | 第 2 类 | 21 CFR 884.5300 | 23 |
| MOV | Catheters, Salpingography | 第 2 类 | 21 CFR 884.4530 | 5 |
| MPT | Contraception Calculator | 第 2 类 | 21 CFR 884.5350 | 1 |
| MPU | Source, Chemiluminescent Light | 第 2 类 | 21 CFR 884.4530 | 2 |
| MQE | Needle, Assisted Reproduction | 第 2 类 | 21 CFR 884.6100 | 33 |
| MQF | Catheter, Assisted Reproduction | 第 2 类 | 21 CFR 884.6110 | 53 |
| MQG | Accessory, Assisted Reproduction | 第 2 类 | 21 CFR 884.6120 | 47 |
| MQH | Microtools, Assisted Reproduction (Pipettes) | 第 2 类 | 21 CFR 884.6130 | 26 |
| MQI | Microtool Fabrication, Assisted Reproduction | 第 2 类 | 21 CFR 884.6140 | |
| MQJ | Micromanipulators And Microinjectors, Assisted Reproduction | 第 2 类 | 21 CFR 884.6150 | 23 |
| MQK | Labware, Assisted Reproduction | 第 2 类 | 21 CFR 884.6160 | 50 |
| MQL | Media, Reproductive | 第 2 类 | 21 CFR 884.6180 | 260 |
| MRX | System, Assisted Reproduction Laser | 第 2 类 | 21 CFR 884.6200 | 11 |
| MSC | Barrier, Std, Oral Sex | 第 2 类 | 21 CFR 884.5300 | 7 |
| MTW | System, Water, Reproduction, Assisted, And Purification | 第 2 类 | 21 CFR 884.6170 | 2 |
| MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 第 1 类 | 21 CFR 884.6190 | |
| NBV | Device, Engorgement, Clitoral | 第 2 类 | 21 CFR 884.5970 | 3 |
| NBZ | Clamp And Cutter, Umbilical | 第 2 类 | 21 CFR 884.4530 | 1 |
| NHM | Sheet, Recording, Breast Examination | 第 2 类 | 21 CFR 884.2990 | 2 |
| NKA | System, Documentation, Breast Lesion | 第 2 类 | 21 CFR 884.2990 | 4 |
| NKC | Tubing/Tubing With Filter, Insufflation, Laparoscopic | 第 1 类 | 21 CFR 884.1730 | |
| NMG | Forceps, Biopsy, Gynecological, Reprocessed | 第 2 类 | 21 CFR 884.4530 | |
| NMH | Laparoscope And Accessories, Gynecologic, Reprocessed | 第 2 类 | 21 CFR 884.1720 | |
| NMI | Laparoscopic Insufflator And Accessories, Reprocessed | 第 1 类 | 21 CFR 884.1730 | |
| NNB | Needle, Reproduction, Assisted, Reprocessed | 第 2 类 | 21 CFR 884.6100 | |
| NRC | Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic | 第 1 类 | 21 CFR 884.5425 | |
| NUC | Lubricant, Personal | 第 2 类 | 21 CFR 884.5300 | 247 |
| NUQ | Pad, Menstrual, Reusable | 第 1 类 | 21 CFR 884.5435 | 1 |
| NUR | Pad, Menstrual, Intralabial | 第 1 类 | 21 CFR 884.5435 | |
| NVT | Tubing And Tubing/Filter Fits | 第 1 类 | 21 CFR 884.1700 | |
| NWV | Laparoscopic Accessories, Gynecologic | 第 1 类 | 21 CFR 884.1720 | |
| NWW | Hysteroscope Accessories | 第 1 类 | 21 CFR 884.1690 | |
| OBB | Kit, Conception-Assist, Home Use | 第 2 类 | 21 CFR 884.5250 | 4 |
| OBY | Condom, Female, Animal Tissue | 第 3 类 | 21 CFR 884.5330 | |
| OCQ | Laparoscopic Bladder-Neck Suspension Instrument, Stress Urinary Incont | 第 2 类 | 21 CFR 884.1720 | |
| OHC | Obstetrical Vacuum Delivery Kit | 第 2 类 | 21 CFR 884.4340 | |
| OHD | Gynecological Laparoscopic Kit | 第 2 类 | 21 CFR 884.1720 | |
| OHE | Forensic Evidence Sexual Assault Kit | 第 2 类 | 21 CFR 884.1630 | |
| OHF | Culdocentesis Kit | 第 2 类 | 21 CFR 884.1640 | |
| OHG | Circumcision Tray | 第 2 类 | 21 CFR 884.4530 | |
| OHH | Breast Pump Kit | 第 2 类 | 21 CFR 884.5160 | |
| OHL | Pap Smear Kit | 第 2 类 | 21 CFR 884.4530 | |
| OHM | Cesarean Section Tray | 第 2 类 | 21 CFR 884.1720 | |