FDA Device Intelligence
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Cannula, Surgical, General & Plastic Surgery

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

8,282
Registered devices
1,037
Adverse events
24
Recalls
36
510(k) clearances

Devices with this code

N/A — SHIPPERT MEDICAL TECHNOLOGIES, INCMarina Medical — MARINA MEDICAL INSTRUMENTS, INC.N/A — BLACK & BLACK SURGICAL, INC.Surgical Instrument — Jeil Medical CorporationMillennium — Avalign Technologies, Inc.BR Surgical, LLC — BR Surgical, LLCBlack & Black Surgical — BLACK & BLACK SURGICAL, INC.Marina Medical — MARINA MEDICAL INSTRUMENTS, INC.PDO Max Cannulas — Max Pdo IncBOSS Instruments — BOSS INSTRUMENTS, LTD., INC.Ace Medical — Ebner Medical, LLCN/A — BLACK & BLACK SURGICAL, INC.SUMMIT MEDICAL — Summit Medical, Inc.N/A — BLACK & BLACK SURGICAL, INC.BR Surgical, LLC — BR Surgical, LLCBlack & Black Surgical — BLACK & BLACK SURGICAL, INC.NA — Zimmer, Inc.BOSS Instruments — BOSS INSTRUMENTS, LTD., INC.N/A — SHIPPERT MEDICAL TECHNOLOGIES, INC2-HOLE STANDARD — The Wells Johnson CompanyMarina Medical — MARINA MEDICAL INSTRUMENTS, INC.Adler Instrument Company — Adler, Inc.Natura — GENICON, INC.N/A — BLACK & BLACK SURGICAL, INC.

Recent recalls

DateFirmReason
2024-12-03Sklar InstrumentsReports of various packaging issues that may result in a breach of the sterile barrier.
2021-04-01CLINICAL LASERTHERMIA SYSTEMS ABsingle use devices labeled as sterile may not have been adequately sterilized
2020-01-15Cardinal Health 200, LLCNon-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization proces
2019-07-16TeDan Surgical Innovations LLCThere was incorrect raw material used in the production of the identified lot.
2018-08-21Genicon, Inc.There is potential for the plastic optical tip to become detached from the metal shaft.
2018-08-21Genicon, Inc.There is potential for the plastic optical tip to become detached from the metal shaft.
2018-08-21Genicon, Inc.There is potential for the plastic optical tip to become detached from the metal shaft.
2018-08-21Genicon, Inc.There is potential for the plastic optical tip to become detached from the metal shaft.
2018-08-21Genicon, Inc.There is potential for the plastic optical tip to become detached from the metal shaft.
2018-08-21Genicon, Inc.There is potential for the plastic optical tip to become detached from the metal shaft.

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