FDA Device Intelligence
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Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

FDA product code ERL · Class 2 · Ear, Nose, Throat

3,221
Registered devices
29,783
Adverse events
29
Recalls
91
510(k) clearances

Devices with this code

NA — Synthes GmbHPiezomed Pro Accessory — W & H Dentalwerk Bürmoos GmbHBur PM2-70 80K Diamond coarse Ø3.0 sterile — Bien-Air Surgery SAMidas Rex — MEDTRONIC POWERED SURGICAL SOLUTIONSENT MR8 — MEDTRONIC POWERED SURGICAL SOLUTIONSPMRM 1122 95mm — Bien-Air Surgery SAXPS Nexus — MEDTRONIC XOMED, INC.NA — Synthes GmbHNA — STRYKER CORPORATIONSTRAIGHTSHOT® — MEDTRONIC XOMED, INC.NA — STRYKER CORPORATIONMIDAS REX MICROSAWS — MEDTRONIC POWERED SURGICAL SOLUTIONSMIDAS REX MICROSAWS — MEDTRONIC POWERED SURGICAL SOLUTIONSORIGO Foot Pedal — Bien-Air Surgery SACORE — STRYKER CORPORATIONENT MR8 — MEDTRONIC POWERED SURGICAL SOLUTIONSENT MR8 — MEDTRONIC POWERED SURGICAL SOLUTIONSMIDAS REX MR8 — MEDTRONIC POWERED SURGICAL SOLUTIONSMidas Rex Clearview — MEDTRONIC XOMED, INC.NA — Synthes GmbHMidas Rex® — MEDTRONIC POWERED SURGICAL SOLUTIONSMidas Rex Clearview — MEDTRONIC XOMED, INC.NA — Anspach Effort, TheNA — Synthes GmbH

Recent recalls

DateFirmReason
2021-12-15Medtronic Xomed, Inc.As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that
2020-09-11Bien-Air Surgery SaThe magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
2020-09-11Bien-Air Surgery SaThe magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
2020-09-11Bien-Air Surgery SaThe magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
2020-09-11Bien-Air Surgery SaThe magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
2020-09-11Bien-Air Surgery SaThe magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
2020-06-12Medtronic Xomed, Inc.During internal testing execution of the next generation of Integrated Power Console (IPC) prototype it was noted that the M5 Microdebrider was rotating at a hi
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.