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U.S. Department of Health and Human Services

510(k) Premarket Notification

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11 to 20 of 500 Results *
Decision Date To: 05/21/2019
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a1at genotyping test Progenika Biopharma S.A., a Grifols company K211115 05/13/2021
accuffrangio ArteryFlow Technology Co., Ltd. K210093 09/10/2021
acqcross qx integrated transseptal dilator/needle Acutus Medical Inc. K210685 04/06/2021
acuitydre Radmedix LLC K210919 04/30/2021
acumed clavicle hook plating system Acumed LLC K210750 07/15/2021
acupebble sa Acurable Limited K210480 07/06/2021
admiral acp system SeaSpine Orthopedics Corporation K212139 09/01/2021
advantage-c peek cervical lnterbody fusion device lntelivation, LLC K211501 08/24/2021
aero chrome* select breathable performance surgical gown, aero chrome* a-line breathable performance surgical gown O&M Halyard, Inc K210688 07/21/2021
air compression therapy device, model hw6007 Konliking Tech & Dev. Limited K210240 02/22/2021

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
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