Home › Device types › EQJ
Bur, Ear, Nose And Throat
FDA product code EQJ · Class 1 · Ear, Nose, Throat
2,277
Registered devices
2,714
Adverse events
4
Recalls
18
510(k) clearances
Devices with this code
Bur PM2-70 80K Diamond coarse Ø3.0 sterile — Bien-Air Surgery SAGyrus ACMI — ProvisionDiego — Gyrus ACMI, LLCORIGO Foot Pedal — Bien-Air Surgery SAN/A — MEDTRONIC XOMED, INC.N/A — MEDTRONIC XOMED, INC.Wexler Surgical, Inc. — WEXLER SURGICAL, INC.StraightShot — MEDTRONIC XOMED, INC.ShBlade 120°concv Ø4.0mm DS St — Bien-Air Surgery SARAD® — MEDTRONIC XOMED, INC.GYRUS ACMI — Gyrus ACMI, LLCRAD® — MEDTRONIC XOMED, INC.Oto-Flex — MEDTRONIC XOMED, INC.N/A — MEDTRONIC XOMED, INC.DIEGO — Gyrus ACMI, LLCVisao® — MEDTRONIC XOMED, INC.DragonFly™ BUR, DMD, RD, 95MM L, 0.5MM Ø — Grace Medical, Inc.GYRUS ACMI — Gyrus ACMI, LLCGyrus ACMI — Gyrus ACMI, LLCDIEGO ELITE — Gyrus ACMI, LLCBur PM2-70 80K steelØ1.0x80 St — Bien-Air Surgery SATricut® — MEDTRONIC XOMED, INC.N/A — MEDTRONIC XOMED, INC.NSK Sterile Burs/Drills — NAKANISHI INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-07-05 | Medtronic Xomed, Inc. | Product was distributed past expiration date. |
| 2021-08-31 | Medtronic Xomed, Inc. | There was an increase in complaints related to tip breaks and wobble/vibration. |
| 2017-08-03 | Gyrus ACMI, Inc. | "Chattering" when cutting burrs are used in bone. |
| 2002-01-25 | Medtronic Xomed, Inc. | Product packaging pouches may be open thereby compomising the sterile barrier. |
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