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US Approvals Analysis: Cook Churns Out 510(k)s In Q3

 
• By David Filmore

The privately held Indiana-based device firm has accelerated its 510(k)-clearance output this year, leading all firms with 19 in the third quarter, and pulling neck-and-neck with perennial leader Medtronic for 2017. Overall, FDA remains relatively steady on 510(k) volumes and is maintaining its accelerated pace of novel-device approvals.

FDA approved background, 3D rendering, blue street sign

[Editors' note: For sortable and searchable tables of all US and non-US approvals and clearances in 2017 and previous years, check out our Approvals Tracker.]

Cook Group Inc. averaged more than one 510(k) clearance per week last quarter, leading all firms in Q3 and...

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