FDA Device Intelligence
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Instrument, Ligature Passing And Knot Tying

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

1,101
Registered devices
635
Adverse events
5
Recalls
5
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2023-12-29Aesculap IncNeedle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue
2023-12-29Aesculap IncNeedle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue
2020-07-08New Wave Endo-Surgical, Corp.The plastic housing on the device may fracture
2016-11-16Teleflex MedicalThe devices wings may become partially detached from the EFx Shield during use.
2016-03-24Teleflex MedicalIncorrect expiration date was printed on the product label.

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