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Motor, Surgical Instrument, Ac-Powered

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

2,561
Registered devices
18,194
Adverse events
27
Recalls
41
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2023-02-15Pro-Dex IncBattery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have switched manufacturing and expiration dat
2018-09-25Pro-Dex IncVisual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers.
2017-03-28Aesculap Implant Systems LLCDiamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a for
2017-03-28Aesculap Implant Systems LLCDiamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a for
2017-03-28Aesculap Implant Systems LLCDiamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a for
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.

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