Home › Device types › GDG
Hook, Surgical, General & Plastic Surgery
FDA product code GDG · Class 1 · General, Plastic Surgery
0
Registered devices
279
Adverse events
7
Recalls
10
510(k) clearances
Devices with this code
ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONO'Connor Skin Hook — SONTEC INSTRUMENTS, INC.AESCULAP — Aesculap AGgSource — GSOURCE LLCCONVERSE SKIN HOOK — SONTEC INSTRUMENTS, INC.Snowden-Pencer — STERIS CORPORATIONLife Instruments — Life Instrument CorporationBR Surgical, LLC — BR Surgical, LLCHayden Medical — Hayden Medical, Inc.Buxton BioMedical — Buxton Biomedical IncAESCULAP — Aesculap AGSklar® — SKLAR CORPORATIONMILLENNIUM — Avalign Technologies, Inc.Surtex — SURTEX INSTRUMENTS LTD.Integra® Jarit® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHOOK — KLS-Martin L.P.Millennium — Avalign Technologies, Inc.HOOK — KLS-Martin L.P.HOOK — KLS-Martin L.P.Life Instruments — Life Instrument CorporationTSI — TEDAN SURGICAL INNOVATIONS, L.L.C.N/A — GEORGE TIEMANN & CO.AESCULAP — Aesculap AGLINK Instruments - Retractors, bone levers, elevators — WALDEMAR LINK GmbH & Co. KG
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2024-11-12 | MEDLINE INDUSTRIES, LP - Northfield | Weak 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. |
| 2024-02-23 | MEDLINE INDUSTRIES, LP - Northfield | Product 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. |
| 2011-12-06 | Teleflex Medical | Teleflex Medical received complaints that the elastic bands are breaking, cracking and /or deteriorating prior to their expiration date. If the elastic bands br |
| 2011-12-06 | Teleflex Medical | Teleflex Medical received complaints that the elastic bands are breaking, cracking and /or deteriorating prior to their expiration date. If the elastic bands br |
| 2008-05-12 | Telefelx Medical | The bands are breaking within the sealed packaging or in use prior to the expiration dates. |
| 2008-05-12 | Telefelx Medical | The bands are breaking within the sealed packaging or in use prior to the expiration dates. |
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