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Panels › Neurology › Product code HBE · Class 2

Drills, Burrs, Trephines & Accessories (Simple, Powered)

Regulation 882.4310

1510(k)s in 12 months (65 all time)
19recalls in 12 months (258 all time)
203recalls that name a 510(k)
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Top companies in HBE

Company510(k)sRecalls
The Anspach Effort, Inc.7104
Stryker Instruments Div. of Stryker Corporation094
Surgify Medical OY419
Stryker714
Stryker Instruments Division of Stryker Corporation013
Aesculap, Inc.50
EXP Pharmaceutical Services Corp04
Medtronic Xomed, Inc.22
Aesculap Implant Systems LLC03
Biomet Microfixation21
DateFirm and productCodeLinked 510(k)
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 7.5 x 7.9 mm Fluted Drum, Extra Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-20-775.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 12.3 x 10.7 mm Fluted Drum, Extra Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-20-123.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 10.5 x 10.7 mm Fluted Drum, Extra Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-20-105.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 6.0 x 7.9 mm Fluted Drum, Extra Long for use with TPS Universal Drill Extra Long "R" Attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-20-60.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 4.7 x 7.9 mm Fluted Drum, Extra Long for use with TPS Universal Drill Extra Long "R" Attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-20-47.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker Round Fluted Bur (9.1 mm) Extra Long for use with TPS Universal Drill Extra Long "R" Attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-10-90.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker Round Fluted Bur (7.6 mm) Extra Long for use with TPS Universal Drill Extra Long "R" Attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-10-75.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker Round Fluted Bur (6.0mm) Extra-Long for use with TPS Universal Drill Extra Long "R" Attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-10-60.
Terminated		 HBEK032303

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