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Log in to start searching through our library of thousands of 483s, or Subscribe Now to 483sOnline.com to uncover exactly what FDA Inspectors are thinking about. It’s your own personal pre-investigation intelligence tool that identifies exactly what investigators are focusing on so you can be prepared – before they show up.

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CoolSystems, Inc.

Issue Date

Jul 01, 2010

Category

Device

Region

Pacific
Investigator(s): Alla Dubrovsky
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Spineology, Inc.

Issue Date

Jun 30, 2010

Category

Device

Region

Central
Investigator(s): Sharon L. Matson
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Concentric Medical, Inc.

Issue Date

Jun 30, 2010

Category

Device

Region

Pacific
Investigator(s): Christine M. Parmentier
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Hansen Medical, Inc.

Issue Date

Jun 28, 2010

Category

Device

Region

Pacific
Investigator(s): Timothy C. Grome
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DocXS Biomedical Products LLC

Issue Date

Jun 28, 2010

Category

Device

Region

Pacific
Investigator(s): Lydia S. Chan
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Chalgren Enterprises, Inc.

Issue Date

Jun 25, 2010

Category

Device
Investigator(s): Mark A. Chen
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Eaton Manufacturing Corp.

Issue Date

Jun 25, 2010

Category

Device

Region

Southwest
Investigator(s): Erica M. Katherine
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Cardea Technologies, Inc.

Issue Date

Jun 21, 2010

Category

Device

Region

Northeast
Investigator(s): Camerson E. Moore, Abby E. Pelletier
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Bionix Development Corp.

Issue Date

Jun 17, 2010

Category

Device

Region

Central
Investigator(s): Eric S. Pittman
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Dane Technologies, Inc.

Issue Date

Jun 17, 2010

Category

Device

Region

Central
Investigator(s): Tony T. Yang
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KT Medical, Inc.

Issue Date

Jun 16, 2010

Category

Device

Region

Southwest
Investigator(s): Elizabeth D. Connell
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Barrx Medical, Inc.

Issue Date

Jun 15, 2010

Category

Device

Region

Pacific
Investigator(s): Linda Linh T. Nguyen
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