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Panels › Neurology › Product code HBG · Class 2

Drills, Burrs, Trephines & Accessories (Manual)

Regulation 882.4300

1510(k)s in 12 months (17 all time)

1recalls in 12 months (54 all time)

40recalls that name a 510(k)

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Top companies in HBG

Company	510(k)s	Recalls
Integra LifeSciences Corp.	0	23
Instrumed International, Inc.	0	14
Integra LifeSciences Corp. d.b.a. Integra Pain Management	0	13
Mri Interventions, Inc.	3	0
Neurodynamics, Inc.	2	0
Pudenz-Schulte Medical Research Corp.	2	0
Ad-Tech Medical Instrument Corporation	0	1
Camino Laboratories, Inc.	1	0
Clinical Neuro Systems, LLC	1	0
Integra Limited	0	1

Date	Firm and product	Code	Linked 510(k)
Jan 13, 2012	Integra LifeSciences Corp. d.b.a. Integra Pain Management 1104HC Integra NeuroSciences Ventricular Bold Monitoring Kit W/ Cranial Access, Drain including (1) Cranial Kit W/Cam. Chuck, (1) Ventricular Bolt ICP Monitoring Kit, (1) CSF Drainage System. Contain Terminated	HBG	K961113
May 13, 2011	Integra LifeSciences Corp. Integra NeuroSciences, Combo Kit, Lot 171237, Integra LifeSciences 3498 West 2400 South, West Valley City, UT 84119. A kit for cranial access containing multiple necessary components to create the bu Terminated	HBG	K961113
May 10, 2011	Integra LifeSciences Corp. Ventricular Bolt Monitoring Kit W/Cranial Access, Drain, 1104HMC, Integra LifeSciences, 3498 West 2400 South, West Valley City, Utah 84119. Kit contains components which are used to monitor Intra Cra Terminated	HBG	K961113
Sep 21, 2009	Integra Life Sciences Corporation Hand Drill - Sterile, Disposable, Convenience Kit, Reorder Number INS030, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other product Terminated	HBG	K961113

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