Home › Device types › HDB
Extractor, Vacuum, Fetal
FDA product code HDB · Class 2 · Obstetrics/Gynecology
164
Registered devices
758
Adverse events
6
Recalls
30
510(k) clearances
Devices with this code
Sun Medical Inc — SUN MEDICAL INCLocking Clasp DCS — Medela AGDisposable overflow protection / bacteria filter — Medela AGBasic rack — Medela AGGiven Vario Pump Kit — Medela AGSuction jar polysulfone 3l — Medela AGCMI — UTAH MEDICAL PRODUCTS, INC.Basic portable — Medela AGMityvac — Coopersurgical, Inc.Silicone tubing — Medela AGSilicone tubing ID 6.5mm, 180cm, 1 coupling piece — Medela AGSpecimen Cup — Medela AGSuction Jar Polysulfone, 1l — Medela AGKiwi® OmniCup® — CLINICAL INNOVATIONS, LLCSerial connection vacuum — Medela AGSerial connection, patient — Medela AGCMI — UTAH MEDICAL PRODUCTS, INC.Y-piece 7/5 mm Disposable System — Medela AGSun Medical Inc — SUN MEDICAL INCTrolley B for DCS — Medela AGSun Medical Inc — SUN MEDICAL INCCMI — UTAH MEDICAL PRODUCTS, INC.Suction Bag 1.5l — Medela AGKiwi® Omni-C Cup® — CLINICAL INNOVATIONS, LLC
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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