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Bur, Ear, Nose And Throat

FDA product code EQJ · Class 1 · Ear, Nose, Throat

2,297
Registered devices
2,763
Adverse events
4
Recalls
18
510(k) clearances

Devices with this code

N/A — MEDTRONIC XOMED, INC.Bur PM2-70 80K FC Ø3.0x80 St — Bien-Air Surgery SABur PM2-70 80K steel Ø3.0 St — Bien-Air Surgery SAN/A — MEDTRONIC XOMED, INC.Gyrus ACMI — Gyrus ACMI, LLCN/A — MEDTRONIC XOMED, INC.RAD — MEDTRONIC XOMED, INC.ShBlade Straight Ø4.0 DS RU St — Bien-Air Surgery SADiego Elite — Gyrus ACMI, LLCGyrus ACMI — Gyrus ACMI, LLCN/A — MEDTRONIC XOMED, INC.JEDMED — JEDMED INSTRUMENT COMPANYDragonFly™ Skinny BUR,100MM x 0.5MM — Grace Medical, Inc.Bur PM2-70 50K Diam Ø4.5 — Bien-Air Surgery SABur PM2-70 80K diam Ø1.0 St — Bien-Air Surgery SABur PM2-70 50K Diam Ø3.1x80 — Bien-Air Surgery SAInvotec ENT Bur — INVOTEC INTERNATIONAL, INC.n.a. — Karl Storz GmbH & Co. KGHS Barr.Burr,Ø4.0x8.0x95,80k — Bien-Air Surgery SAn/a — Hager & Meisinger Gesellschaft mit beschränkter HaftungN/A — MEDTRONIC XOMED, INC.n.a. — Karl Storz GmbH & Co. KGBur PM2-125 80K Diam C Ø3.1 St — Bien-Air Surgery SABur PM2-70 50K Steel Ø1.4 — Bien-Air Surgery SA

Recent recalls

DateFirmReason
2024-07-05Medtronic Xomed, Inc.Product was distributed past expiration date.
2021-08-31Medtronic Xomed, Inc.There was an increase in complaints related to tip breaks and wobble/vibration.
2017-08-03Gyrus ACMI, Inc."Chattering" when cutting burrs are used in bone.
2002-01-25Medtronic Xomed, Inc.Product packaging pouches may be open thereby compomising the sterile barrier.

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