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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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US Vascular LLC

Issue Date

Apr 02, 2019

Category

Device

Region

Pacific
Investigator(s): Stephen R. Souza
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KATALYST, Inc.

Issue Date

Mar 28, 2019

Category

Device

Region

Pacific
Investigator(s): Christopher S. Genther
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Fabtech Precision Manufacturing, Inc.

Issue Date

Mar 08, 2019

Category

Device

Region

Pacific
Investigator(s): Christopher S. Genther
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W.L. Gore & Associates, Inc.

Issue Date

Mar 21, 2019

Category

Device

Region

Pacific
Investigator(s): Quynh H. Strandberg
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ITG-Medev, Inc.

Issue Date

Mar 29, 2019

Category

Device

Region

Pacific
Investigator(s): Janet Pulver
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Phelan Mfg. Corp.

Issue Date

Apr 18, 2019

Category

Device

Region

Central
Investigator(s): Yehualashet A. Gessesse
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Performance Health Supply, Inc.

Issue Date

Apr 17, 2019

Category

Device

Region

Central
Investigator(s): Michelle J. Glembin
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Heraeus Medical Components, LLC

Issue Date

Apr 26, 2019

Category

Device

Region

Central
Investigator(s): Susan M. Matthias
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Caerus Corp.

Issue Date

Apr 24, 2019

Category

Device

Region

Central
Investigator(s): Jennifer S. Ness
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The Metrix Co.

Issue Date

Apr 25, 2019

Category

Device

Region

Southwest
Investigator(s): Edward Lockwood
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Jim G. Aukstuolis

Issue Date

Feb 01, 2019

Category

Clinical

Region

Southwest
Investigator(s): Camille D. Brown, Denise L. Burosh
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Garth O. Vaz

Issue Date

Feb 01, 2019

Category

Clinical

Region

Southwest
Investigator(s): Leighton K. Ngai
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