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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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Penumbra, Inc.

Issue Date

Aug 24, 2010

Category

Device

Region

Pacific
Investigator(s): Linda S. Shook
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Peak Surgical, Inc.

Issue Date

Aug 18, 2010

Category

Device

Region

Pacific
Investigator(s): Christine M. Parmentier
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Defibtech, LLC

Issue Date

Aug 18, 2010

Category

Device

Region

Northeast
Investigator(s): George T. Allen, Edward J. Janik
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Dental Prosthetic Services, Inc.

Issue Date

Aug 18, 2010

Category

Device

Region

Southwest
Investigator(s): John A. Iwen
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Invacare Corp.

Issue Date

Aug 18, 2010

Category

Device

Region

Southeast
Investigator(s): Andrea H. Norwood, Richard K. Vogel
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INO Therapeutics

Issue Date

Aug 17, 2010

Category

Device

Region

Central
Investigator(s): Michelle J. Glembin
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iScience Interventional

Issue Date

Aug 16, 2010

Category

Device

Region

Pacific
Investigator(s): Lydia S. Chan
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Howmedica Osteonics Corp.

Issue Date

Aug 12, 2010

Category

Device

Region

Central
Investigator(s): Robert G. Ruff
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Abbott Point of Care, Inc.

Issue Date

Aug 11, 2010

Category

Device

Region

Central
Investigator(s): Kinh Q. Mac
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Align Technology, Inc.

Issue Date

Aug 09, 2010

Category

Device

Region

Pacific
Investigator(s): Linda Linh T. Nguyen
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Hitachi Chemical Diagnostics, Inc.

Issue Date

Aug 06, 2010

Category

Device

Region

Pacific
Investigator(s): Jeffrey W. Shrifter
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Hospira, Inc.

Issue Date

Jul 28, 2010

Category

Device

Region

Pacific
Investigator(s): Timothy C. Grome
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