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U.S. Department of Health and Human Services

510(k) Premarket Notification

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61 to 70 of 500 Results *
Decision Date To: 07/22/2019
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tunneloc tibial fixation device Biomet Inc. K193092 01/02/2020
ureteral stent systems, biliary drainage catheters Boston Scientific Corporation K191446 01/02/2020
sterile leadconfirm Alpha Omega Engineering Ltd. K191739 01/02/2020
air next NuvoAir AB K183089 01/02/2020
invacare aviva fx power wheelchair, model: ifx-20mp Invacare Corporation K192216 01/02/2020
optilume basic urological balloon dilation catheter Urotronic Inc K191061 01/02/2020
acuity sdr standard, acuity sdr plus, acuity fdr standard Radmedix LLC K193360 01/02/2020
incore tmt system Nextremity Solutions, Inc. K192578 12/31/2019
automistar Apollo Medical Imaging Technology Pty. Ltd. K192912 12/31/2019
radcalc software LifeLine Software, Inc. K193381 12/31/2019

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