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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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3m comply hydrogen peroxide chemical indicator 3M Company K192937 11/16/2019
dornier ureteral stent Dornier MedTech America Inc. K190312 11/15/2019
hemotrol duo low, hemotrol duo normal, hemotrol duo high Eurotrol B.V. K192842 11/15/2019
pentax medical video duodenoscope ed34-i10t2 PENTAX of America, Inc. K192245 11/15/2019
em sa implant system Hiossen, Inc. K191201 11/15/2019
irraflow catheter, irraflow tube set, irraflow control unit IRRAS USA, Ltd. K192289 11/15/2019
drsplus CenterVue SpA K192113 11/15/2019
arcus head fixation frame MRI Interventions, Inc. K191701 11/15/2019
cooltone Zimmer MedizinSysteme GmbH K192940 11/15/2019
keyprint keysplint soft Keystone Industries K183598 11/15/2019

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