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© 2019 by Graematter

Medical Device Today

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Collected and updated throughout the day to keep you informed.  Come back often!

 

CDRH Guidance

New

2019 YTD

Withdrawn

2019 YTD

510(k) Clearances

Notable

Two 510(k)s for Combination products cleared last week. K191016 and K192440

One 510(k) with clinical data cleared last week.  K190896

Cleared

2019 YTD

Cleared

Last Week

 
 

De Novo Approvals

Approved

2019 YTD

 

De Novo Review Days Distribution

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Approved 2019 YTD

PMA Approvals

Original

Supplements

 

Consensus Standards - New & Revised

New & Revised

Q3 2019

New & Revised

2019 YTD

 

Product Codes - New & Withdrawn

New Codes

2019 YTD

Withdrawn 

2019 YTD

NOTES (as of 10/14/2019)

There are 2 product codes associated with a PMA, 510(k), or De Novo that do not appear in the online FDA Classification database.  

PRD - DEN160048 Approved 2/14/2017 &  K170883 Cleared 06/22/2017

QBW - K180217 Cleared 05/18/2018

Finally made it to the online database on 10/14:

PRH - DEN160032 Approved 02/23/2017

QHH - DEN180057 Approved 06/07/2019

QCT - P180043 Approved 4/11/2019

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