FDA Device Intelligence
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System, Abortion, Vacuum

FDA product code HHI · Class 2 · Obstetrics/Gynecology

19
Registered devices
46
Adverse events
2
Recalls
24
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2019-09-12Olympus Corporation of the AmericasBerkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could separate
2016-05-19Richard Wolf Medical Instruments Corp.The distal end of the Conical portio adapter (acorn) is composed of a small cap (head) that partially sits inside a hollow shaft (tube). These two parts are wel

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.