Panels › Obstetrics/Gynecology
Obstetrics/Gynecology devices
180 product codes reviewed by the Obstetrics/Gynecology panel. 4,633 510(k) clearances and 812 recalls in the FDA data, 43% of those recalls name a 510(k).
104510(k)s in 12 months
114recalls in 12 months
351recalls that name a 510(k)
Active product codes, Class II
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| HGX | Pump, Breast, Powered | 2 | 39 | 0 |
| OHD | Gynecological Laparoscopic Kit | 2 | 0 | 22 |
| HIF | Insufflator, Laparoscopic | 2 | 3 | 15 |
| NUC | Lubricant, Personal | 2 | 15 | 0 |
| OJF | Hysterectomy Kit | 2 | 0 | 15 |
| OKV | Obstetrical Kit | 2 | 0 | 15 |
| OHM | Cesarean Section Tray | 2 | 0 | 14 |
| HIH | Hysteroscope (And Accessories) | 2 | 8 | 4 |
| MLS | Labor And Delivery Kit | 2 | 0 | 11 |
| HGM | System, Monitoring, Perinatal | 2 | 2 | 5 |
| OHG | Circumcision Tray | 2 | 0 | 6 |
| HIS | Condom | 2 | 3 | 1 |
| HEB | Tampon, Menstrual, Unscented | 2 | 2 | 1 |
| HIG | Insufflator, Hysteroscopic | 2 | 2 | 1 |
| MQK | Labware, Assisted Reproduction | 2 | 3 | 0 |
| MQL | Media, Reproductive | 2 | 3 | 0 |
| HIB | Speculum, Vaginal, Nonmetal | 2 | 1 | 1 |
| LKF | Cannula, Manipulator/Injector, Uterine | 2 | 2 | 0 |
| MLT | Pelvic Exam Kit | 2 | 0 | 2 |
| MQG | Accessory, Assisted Reproduction | 2 | 2 | 0 |
| HDB | Extractor, Vacuum, Fetal | 2 | 0 | 1 |
| HFX | Clamp, Circumcision | 2 | 1 | 0 |
| HHW | Pessary, Vaginal | 2 | 1 | 0 |
| HIR | Perineometer | 2 | 1 | 0 |
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | 2 | 1 | 0 |
| KNG | Monitor, Ultrasonic, Fetal | 2 | 1 | 0 |
| LQK | Home Uterine Activity Monitor | 2 | 1 | 0 |
| MOL | Condom, Synthetic | 2 | 1 | 0 |
| MQE | Needle, Assisted Reproduction | 2 | 1 | 0 |
| MQF | Catheter, Assisted Reproduction | 2 | 1 | 0 |
| MQH | Microtools, Assisted Reproduction (Pipettes) | 2 | 1 | 0 |
| MRX | System, Assisted Reproduction Laser | 2 | 1 | 0 |
| MSC | Barrier, Std, Oral Sex | 2 | 1 | 0 |
| OQY | Intrauterine Tamponade Balloon | 2 | 1 | 0 |
| PBH | Embryo Image Assessment System, Assisted Reproduction | 2 | 1 | 0 |
| PBQ | Fixation, Non-Absorbable Or Absorbable, For Pelvic Use | 2 | 1 | 0 |
| PFJ | Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor | 2 | 1 | 0 |
| PYT | Device, Fertility Diagnostic, Contraceptive, Software Application | 2 | 1 | 0 |
| SIM | Gynecologic Power Morcellator And Containment System | 2 | 1 | 0 |
Other panels: Anesthesiology · Cardiovascular · Clinical Chemistry · Clinical Toxicology · Dental · Ear, Nose, Throat · Gastroenterology, Urology · General Hospital · General, Plastic Surgery · Hematology · Immunology · Medical Genetics · Microbiology · Neurology · Ophthalmic · Orthopedic · Pathology · Physical Medicine · Radiology