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U.S. Department of Health and Human Services

510(k) Premarket Notification

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31 to 40 of 500 Results *
Decision Date To: 05/21/2019
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platelet and plasma separator for bone graft handling: Healeon Duet Haeleon Medical, Inc. BK200449 08/06/2020
steripack cases and tray systems Avalign Technologies, Inc. K193066 08/06/2020
vicryl mesh Ethicon, Inc. K201143 08/06/2020
latitude ev™ total elbow arthroplasty Tornier Inc. K193247 08/05/2020
mariner cap system SeaSpine Orthopedics Corporation K201240 08/05/2020
modular toga Operating Room Innovations, Inc. K200977 08/05/2020
carboclear navigated instruments CarboFix Orthopedics Ltd. K201251 08/05/2020
nitrile powder free examination glove tested for use with chemotherapy drugs and fentanyl, citrate (fusion dark grey) Hartalega Ngc Sdn. Bhd. K201530 08/05/2020
crossglide ets plus CrossBay Medical K201952 08/05/2020
enhanced external counter pulsation device plus omay-a Omay(Guangzhou)Med Technologies Co., Ltd. K191955 08/05/2020

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