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U.S. Department of Health and Human Services

510(K) Premarket Notification

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Device Name
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510(K)
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Decision
Date
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peri-guard repair patch, supple peri-guard repair patch Synovis Life Technologies, Inc. k221029 10/19/2022
polaris ds/comet SYNERON MEDICAL LTD. k041959 11/08/2004
celikey igg itg igg antibodies, model 17996 SWEDEN DIAGNOSTICS (GERMANY) GMBH k041173 08/02/2004
gemmed pedicle screw spinal system SUZHOU GEMMED MEDICAL INSTRUMENT CO., LTD. k151592 09/24/2015
aurelia chlorinated powder free latex medical examination gloves with aloe vera and ginseng with protein labeling claim SUPERMAX GLOVE MANUFACTURING SDN BHD k013953 02/26/2002
ulceloocin oral ulcer patch SUNSHINE INTERNATIONAL GROUP, INC. k070842 06/07/2007
stryker cmf medpor priority customized implant kit Stryker Leibinger GmbH & Co. KG k191916 08/15/2019
stryker resorbable fixation system Stryker Leibinger GmbH & Co. KG k230733 08/05/2023
ortho guidance precision knee software; ortho guidance express knee software; ortho guidance versatile hip software; q guidance system Stryker Leibinger GmbH & Co. KG k233542 03/14/2024
colorado microdissection needle STRYKER LEIBINGER k000348 05/03/2000

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