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

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

3,231
Registered devices
30,024
Adverse events
29
Recalls
91
510(k) clearances

Devices with this code

POWERFORMA® — MEDTRONIC XOMED, INC.NA — Synthes GmbHMidas Rex Clearview — MEDTRONIC XOMED, INC.Diego — Gyrus ACMI, LLCNA — Anspach Effort, TheNA — Anspach Effort, TheNA — Synthes GmbHBur PM2-70 80K Steel Ø2.7 St — Bien-Air Surgery SAMidas Rex — MEDTRONIC POWERED SURGICAL SOLUTIONSMatrix — Synthes GmbHBur PM2-70 80K diamC Ø1.0 St — Bien-Air Surgery SAHS Diam. Burr, Ø1.8x150, 80k — Bien-Air Surgery SAENT MR8 — MEDTRONIC POWERED SURGICAL SOLUTIONSHS Dia.Burr,coarse,Ø4.0x95,80k — Bien-Air Surgery SAn.a. — Karl Storz GmbH & Co. KGBASCH Cable — Bien-Air Surgery SANSK Sterile Burs/Drills — NAKANISHI INC.NA — Synthes GmbHBur PM2-150 80K Diam C Ø4.0 St — Bien-Air Surgery SAENT MR8 — MEDTRONIC POWERED SURGICAL SOLUTIONSMidas Rex ™ — MEDTRONIC POWERED SURGICAL SOLUTIONSNA — Synthes GmbHNSK Sterile Burs/Drills — NAKANISHI INC.Midas Rex ™ — MEDTRONIC POWERED SURGICAL SOLUTIONS

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.