FDA Device Intelligence
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Hook, Surgical, General & Plastic Surgery

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

3,122
Registered devices
277
Adverse events
7
Recalls
10
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2024-12-03Sklar InstrumentsReports of various packaging issues that may result in a breach of the sterile barrier.
2024-11-12MEDLINE INDUSTRIES, LP - NorthfieldWeak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
2024-02-23MEDLINE INDUSTRIES, LP - NorthfieldProduct may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
2011-12-06Teleflex MedicalTeleflex Medical received complaints that the elastic bands are breaking, cracking and /or deteriorating prior to their expiration date. If the elastic bands br
2011-12-06Teleflex MedicalTeleflex Medical received complaints that the elastic bands are breaking, cracking and /or deteriorating prior to their expiration date. If the elastic bands br
2008-05-12Telefelx MedicalThe bands are breaking within the sealed packaging or in use prior to the expiration dates.
2008-05-12Telefelx MedicalThe bands are breaking within the sealed packaging or in use prior to the expiration dates.

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