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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)
Feb 14, 2011Stryker Instruments Division of Stryker Corporation
Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone
Terminated		 HBEK032303
Feb 14, 2011Stryker Instruments Division of Stryker Corporation
Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone
Terminated		 HBEK032303
Feb 14, 2011Stryker Instruments Division of Stryker Corporation
Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone
Terminated		 HBEK032303
Feb 14, 2011Stryker Instruments Division of Stryker Corporation
Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone
Terminated		 HBEK032303
Jan 11, 2010Stryker Instruments Div. of Stryker Corporation
Stryker MIS Bur, 3.0mm Neuro Diamond Course, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-230.
Terminated		 HBEK032303
K040300
Jan 11, 2010Stryker Instruments Div. of Stryker Corporation
Stryker MIS Bur, 3.5mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-135.
Terminated		 HBEK032303
K040300
Jan 11, 2010Stryker Instruments Div. of Stryker Corporation
Stryker MIS Bur, 3.0mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-130.
Terminated		 HBEK032303
K040300
Jan 11, 2010Stryker Instruments Div. of Stryker Corporation
Stryker MIS Bur, 2.5mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-125.
Terminated		 HBEK032303
K040300
Jan 11, 2010Stryker Instruments Div. of Stryker Corporation
Stryker MIS Bur, 2.0mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-120.
Terminated		 HBEK032303
K040300
Dec 16, 2009Biomet Microfixation, Inc.
Biomet 1.1 X 50MM, 3.5MM STOP STAINLESS STEEL, 1.5MM SYSTEM TWIST DRILL WITH J NOTCH, REF 01-7141. DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA. A single use
Terminated		 HBEK062842
Oct 28, 2009The Anspach Effort, Inc.
Foot Pedal, Foot Control for SC2000 and SC2100 Powered, simple cranial drills, burrs, trephines, and their accessories. Catalog Numbers: EMAX2-FP and FPLUS-FP. Indicated to cut and shape bone includ
Terminated		 HBEK011444
K080802
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker Instruments Minor modification product, 550-19-20 with 304.8mm length, sterile, product of Ireland, Stryker Instruments, Kalamazoo, MI; REF 5500019020S3.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker Instruments 7.0mm Round Fluted Bur Extra Long, for use with TPS Universal Drill Extra Long "R" attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5260-10-70.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker Instruments 6.5mm Round Fluted Bur Extra Long for use with TPS Universal Drill Extra Long "R" attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5260-10-65.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 5.0mm Round Fluted Bur, Extra Long, for use with TPS Universal Drill Extra Long "R" attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5260-10-50.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 3.0mm x 3.8mm Precision Neuro Drill Extended Long for use with Long "AM" attachments, sterile, Stryker Instruments, Kalamazoo, MI; REF 5230-107-530S1.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 32.mm x 18.3mm Heliocoidal Rasp Super Long, for use with "RX" attachments, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-80-30.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 3.0mm x 34.9mm Straight Router, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-70-230.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 3.1mm x 19.1mm Straight Router, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-70-31.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 9.0mm x 11.4mm Acorn Bur, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-30-90.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 7.5mm x 9.5mm Acorn Bur, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-30-75.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 6.0mm x 8.0mm Acorn Bur, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-30-60.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 9.1mm x 7.9mm XX Coarse Diamond Drum, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-21-991.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 7.5mm x 7.9mm XX Coarse Diamond Drum, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-21-775.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 9.1mm x 7.9mm Fluted Drum, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-20-991.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 7.8mm x 7.9mm Fluted Drum, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-20-775.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 12.3mm x 10.7mm Fluted Drum, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-20-123.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 10.5mm x 10.7mm Fluted Drum, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-20-105.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 6.0mm x 7.9 mm Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-20-60.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 4.7mm x 7.9mm Fluted Drum, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-20-47.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 6.0 mm Barrel Bur, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-17-60.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker Instruments 8.omm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-13-180.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker Instruments 7.0mm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-13-170.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 6mm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-13-160.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 5.0 mm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-13-150.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 4.0mm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-13-140.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 10.0 mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-100.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 9.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-90.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 8.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-80.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 7.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-70.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 6.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-60.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 5.0mm Round Fluted Bur,Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-50.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 4.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-40.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 3.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-30.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 2.0 mm x 3.8 mm Neuro Drill, Extra Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-107-30.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker Tapered Router Extra Long (2.3mm x 22.0mm) for use with extra long "R" Attachments, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-71-223.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 3.1 mm x 19.1 mm Straight Router, Extra Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-70-31.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 9.1 x 11.4 mm Acorn Bur, Extra Long, Stryker Instruments, Kalamazoo, MI; REF 5160-30-90.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 7.5 x 9.5 mm Acorn Bur, Extra long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-30-75.
Terminated		 HBEK032303
Apr 22, 2008Stryker Instruments Div. of Stryker Corporation
Stryker 6.1 x 8.0 mm Acorn Bur, Extra long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-30-60.
Terminated		 HBEK032303

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