Home › Device types › HDB
Extractor, Vacuum, Fetal
FDA product code HDB · Class 2 · Obstetrics/Gynecology
164
Registered devices
751
Adverse events
6
Recalls
30
510(k) clearances
Devices with this code
Sun Medical Inc — SUN MEDICAL INCMityvac — Coopersurgical, Inc.Kiwi® OmniCup® — CLINICAL INNOVATIONS, LLCDouble set 5l — Medela AGDisposable Specimen Cup — Medela AGGiven Vario Pump Kit — Medela AGSun Medical Inc — SUN MEDICAL INCDisposable Overflow Protection / Virus Filter — Medela AGKiwi® Omni-C Cup® — CLINICAL INNOVATIONS, LLCMityvac — Coopersurgical, Inc.Sun Medical Inc — SUN MEDICAL INCSerial connection, patient — Medela AGLarge lid with conical patient connection 6–10 mm — Medela AGCMI — UTAH MEDICAL PRODUCTS, INC.Foot ON/OFF switch for Basic/Dominant — Medela AGSun Medical Inc — SUN MEDICAL INCSuction jar polysulfone 5l — Medela AGSuction Bag 1.5l — Medela AGSun Medical Inc — SUN MEDICAL INCClamp holder, plastic — Medela AGFilter paper for autoclavable bacteria filter — Medela AGSilicone Birth Vac Cup — FORTUNE MEDICAL INSTRUMENT CORP.CMI — UTAH MEDICAL PRODUCTS, INC.Suction jar polysulfone 0.25l — Medela AG
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-09 | Clinical Innovations, LLC | Due to complaints of device breakage at the traction force gauge to handle joint. |
| 2019-08-06 | Clinical Innovations, LLC | There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system. |
| 2008-01-16 | Cooper Surgical, Inc. | Vacuum Assisted Delivery System may have a loss of vacuum, or the cup will not release from the baby's head. A loss of vacuum may delay delivery and require the |
| 2008-01-16 | Cooper Surgical, Inc. | Vacuum Assisted Delivery System may have a loss of vacuum, or the cup will not release from the baby's head. A loss of vacuum may delay delivery and require the |
| 2008-01-16 | Cooper Surgical, Inc. | Vacuum Assisted Delivery System may have a loss of vacuum, or the cup will not release from the baby's head. A loss of vacuum may delay delivery and require the |
| 2004-08-17 | CooperSurgical, Inc. | Product is mislabeled as a Mushroom Cap Vacuum but actually contains a Bell Style Assisted Delivery System |
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