ClearanceBrief
Panels › Ear, Nose, Throat › Product code EQJ · Class 1

Bur, Ear, Nose And Throat

Regulation 874.4140

0510(k)s in 12 months (18 all time)
0recalls in 12 months (4 all time)
0recalls that name a 510(k)
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Top companies in EQJ

Company510(k)sRecalls
Trebay Medical Corp.50
Medtronic Xomed, Inc.13
KARL STORZ Endoscopy-America, Inc.30
American Sterilizer Co.10
Cmsi10
Gyrus ACMI, Inc.01
Gyrus Ent LLC10
Mednext, Inc.10
Micromedics, Inc.10
Smith & Nephew Richards, Inc.10
DateFirm and productCodeLinked 510(k)
Sep 12, 2024Medtronic Xomed, Inc.
Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069
Open, Classified		 EQJNone listed
Oct 21, 2021Medtronic Xomed, Inc.
Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following produ
Open, Classified		 EQJNone listed
Mar 20, 2018Gyrus ACMI, Inc.
Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
Open, Classified		 EQJNone listed
Mar 20, 2003Medtronic Xomed, Inc.
Product is labeled as ''Oto-''Flex Bur'', Medtronic-Xomed brand, packed into a sterile pouch. Product is further packaged into a shelf box with similar labeling as follows: Part Number 31-55631 Oto-Fl
Terminated		 EQJNone listed

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