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Applier, Hemostatic Clip

FDA product code HBT · Class 1 · General, Plastic Surgery

251
Registered devices
362
Adverse events
14
Recalls
4
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2018-06-19LeMaitre Vascular, Inc.The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU provided lists some indications which are not cleared by the F
2014-01-23Atricure IncThe firm was notified by a customer of a cracked spring in the handle of the RCD1 device.
2010-09-22Lemaitre Vascular, Inc.Mislabeled size on external packaging: The contents section listed on the Tyvek lid labels of the Medium and Large sizes incorrectly identified the size of the
2010-09-22Lemaitre Vascular, Inc.Mislabeled size on external packaging: The contents section listed on the Tyvek lid labels of the Medium and Large sizes incorrectly identified the size of the
2008-08-08Sterilmed IncSteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted becau
2004-08-18WeckThe jaws may break during clip loading or clip application.
2003-10-24WeckHole in the sterile unit blister pack that could compromise sterility.
2003-10-24WeckHole in the sterile unit blister pack that could compromise sterility.
2003-10-24WeckHole in the sterile unit blister pack that could compromise sterility.
2003-10-24WeckHole in the sterile unit blister pack that could compromise sterility.

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