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U.S. Department of Health and Human Services

510(k) Premarket Notification

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61 to 70 of 500 Results *
Decision Date To: 05/21/2019
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promisemed blood lancet, verifine safety lancet, verifine mini-safety lancet Promisemed Hangzhou Meditech Co., Ltd. K192666 12/02/2019
emprint visualization application Covidien LLC. K192038 12/02/2019
ureteral stent open tip/closed tip/intraoperative tip, ureteral stent via ureterorenoscope open tip/closed tip, pediatric ureteral stent open tip/closed tip, mono j urinary diversion ureteral stent open tip/closed tip, multiloop ureteral stent open tip/closed tip Allwin Medical Devices, Inc. K190659 12/02/2019
uroject12 syringe lever UroGen Pharma Ltd. K190987 12/02/2019
resorbable mesh device SeaSpine Orthopedics Corporation K193040 11/30/2019
innonix antiviral child's face mask Innonix Technologies Limited K192105 11/29/2019
asahi crosswalk peripheral support catheter Asahi Intecc Co., Ltd. K192782 11/29/2019
i-portal neuro otologic test center, i-portal video nystagmography system, i-portal portable assessment system - nysragmograph Neurolign USA, LLC K192186 11/29/2019
axs infinity ls plus long sheath Stryker Neurovascular K193034 11/29/2019
elia symphonys immunoassay Phadia AB K190710 11/29/2019

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