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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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resonic rapid acoustic pulse device Zeltiq Aesthetics, Inc. K222629 09/25/2022
powder free nitrile examination glove Dainam Glove Joint Stock Company K212751 09/24/2022
single-use medical latex examination gloves (lg100) Fitone Latex Products Co., Ltd. Guangdong K222693 09/24/2022
polyisoprene powder free surgical glove tested for use with chemotherapy drugs (natural) Hartalega NGC SDN BHD K221718 09/24/2022
betel gloves nitrile examination glove powder free Betel care Sdn. Bhd. K222342 09/24/2022
black nitrile powder free patient examination glove, non-sterile, tested for use with chemotherapy drugs, the opioid fentanyl citrate, simulated gastric acid, and fentanyl in gastric acid Onetexx SDN BHD K222294 09/24/2022
nitrile examination glove, pink color; nitrile examination glove, black color, nitrile examination glove, white color Guangdong Kingfa Sci. & Tech. Co., Ltd. K221887 09/24/2022
diosculpt Shanghai Wonderful Opto-Electrics Tech. Co., Ltd. K222265 09/23/2022
hotdog temperature management system Augustine Temperature Management K220941 09/23/2022
platform® acetabular system Total Joint Orthopedics, Inc. K220483 09/23/2022

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