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U.S. Department of Health and Human Services

510(k) Premarket Notification

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101 to 110 of 500 Results *
Decision Date To: 07/22/2019
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fujifilm ultrasonic endoscope Fujifilm Corporation K183433 09/05/2019
holinwon 30 Won Tech Co., Ltd. K183563 09/05/2019
freedom primary pck Maxx Orthopedics, Inc. K192148 09/05/2019
advocate non-contact infrared thermometer BroadMaster Biotech, Corp. K191004 09/05/2019
celerity hp chemical indicator, celerity vaporized vh2o2 process indicator adhesive label, verify v24 self-contained biological indicator vial label STERIS Corporation K192020 09/05/2019
human iga liquid reagent kit for use on spaplus The Binding Site Group Ltd K192116 09/04/2019
myo plus Otto Bock Healthcare Products GmbH K191179 09/04/2019
golnit non-aborbable ptfe surgical suture Antarma LLC dba Golnit Sutures K192088 09/04/2019
mts imipenem 0.016-256 µg/ml Liofilchem s.r.l. K191908 09/04/2019
opus bulk fill aps, opus bulk fill flow aps DentsCare LTDA K190758 09/04/2019

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