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February 2021 510(K) Clearances - FDA

Mar 6, 2021 · 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD February 2021 DEVICE: Archworx Utah Medical Products ...

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510(k) Clearances - FDA

www.fda.gov › medical-devices › device...

5 days ago · Browse and Search for 510(k) Clearances. Search the 510(k) Premarket Notification database. Browse for Clearances by Year. 510(k) Devices ...

Search the Releasable 510(k... · Medical Device Safety and the...

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510(k) Devices Cleared in 2021 - FDA

www.fda.gov › medical-devices

Nov 6, 2023 · This page lists all medical devices cleared through the CDRH Premarket Notification process [510(K)] in 2021.

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February 2023 510(K) Clearances - FDA

www.fda.gov › medical-devices

Mar 6, 2023 · 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD February 2023 DEVICE: Insulin syringe with integrated ...

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April 2021 510(K) Clearances - FDA

www.fda.gov › medical-devices

May 5, 2021 · 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD April 2021 DEVICE: Velocity Alpha Highspeed Surgical ...

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February 2022 510(K) Clearances - FDA

www.fda.gov › medical-devices

Mar 7, 2022 · 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD February 2022 DEVICE: CardioChek Plus Test System; ...

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Premarket Notification 510(k) - FDA

www.fda.gov › medical-devices › prema...

Dec 5, 2023 · The submitter may market the device immediately after 510(k) clearance is granted. The manufacturer should be prepared for an FDA quality ...

510(k) Frequently Asked... · Is a new 510(k) required for a... · 510(k) Forms

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May 2021 510(K) Clearances - FDA

www.fda.gov › medical-devices

Jun 8, 2021 · 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD May 2021 DEVICE: Neuro-IOM system with Neuro-IOM.

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November 2022 510(K) Clearances - FDA

www.fda.gov › medical-devices

Dec 5, 2022 · 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD November 2022 DEVICE: Procise CRP, ProciseDx Analyzer, ...

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