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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 500 Results *
Decision Date To: 05/21/2019
 
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091 balloon guide catheter InNeuroCo Inc. K220331 07/29/2022
17hq901g-b LG Electronics Inc. K220559 05/05/2022
3m attest steam chemical integrators (1243a, 1243b, 1243re, 1243res) 3M Company K220942 06/24/2022
3m comply lead free steam indicator tape 1322, 3m attest lead free steam indicator tape 1355 3M Company K220564 05/23/2022
5000 compact series ultrasound systems (ultrasound system 5500 g, ultrasound system 5500 p, ultrasound system 5500 w, ultrasound system 5500 cv, ultrasound system 5300 g, ultrasound system 5300 p, ultrasound system 5300 w) Philips Ultrasound LLC K222648 09/27/2022
accu-chek safe-t-pro plus lancing device Roche Diabetes Care, Inc. K220849 05/19/2022
accu-chek safe-t-pro uno lancing device Roche Diabetes Care, Inc. K220364 04/05/2022
acqcross qx integrated transseptal dilator/needle Acutus Medical, Inc. K220047 02/08/2022
acqguide® vue steerable sheath Acutus Medical, Inc. K221044 05/05/2022
agilon xo shoulder system implantcast, GmbH K222482 09/28/2022

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