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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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510(k) Clearances - FDA

www.fda.gov › medical-devices › device...
Nov 6, 2023 · Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a ...
Search the Releasable 510(k... · 510(k) Devices Cleared in 2023
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510(k) Devices Cleared in 2022 - 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 2022.
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November 2021 510(K) Clearances - FDA

www.fda.gov › medical-devices
Dec 6, 2021 · 510(k) Devices Cleared in 2022 ... Medical Device Safety and the 510(k) Clearance Process ... FDA DEVICE: Clarius Ultrasound Scanner Clarius Mobile ...
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July 2022 510(K) Clearances - FDA

www.fda.gov › medical-devices
Aug 5, 2022 · 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD July 2022 DEVICE: ROTEM sigma Thromboelastometry System ...
Missing: q= november-

August 2022 510(K) Clearances - FDA

www.fda.gov › medical-devices
Sep 6, 2022 · 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD August 2022 DEVICE: Solidence Multipockets Solidence ...
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June 2022 510(K) Clearances - FDA

www.fda.gov › medical-devices
Jul 11, 2022 · 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD June 2022 DEVICE: RoughRider Aurora Manual Wheelchair ...

510(k) Premarket Notification - accessdata.fda.gov

www.accessdata.fda.gov › cfpmn › pmn
A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, ...
Quick Search · De Novo classification · Downloadable 510(k) Files · Print
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FDA 510(k) Clearance - Dangerous Fast-Track Approval Process

www.drugwatch.com › FDA
The FDA 510(k) clearance process allows medical devices to enter the U.S. market with no clinical trial requirement and no evidence that they are safe.

April 2023 510(K) Clearances - FDA

www.fda.gov › medical-devices
May 5, 2023 · 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD April 2023 DEVICE: AUTION MAX AX-4060 Urinalysis System ...
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