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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: 07/22/2019
 
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0.9% sodium chloride injection, usp, pre-filled cop syringe Medline Industries, Inc. K191378 09/15/2019
capmedic Cognita Labs, LLC K183586 09/13/2019
scenaria view Hitachi Healthcare Americas K190841 09/13/2019
acist rxi system and navvus ii catheter ACIST Medical Systems, Inc. K190473 09/13/2019
multi-link x2 ecg and spo2 adapter Vyaire Medical, Inc. K191273 09/13/2019
probeat-cr Hitachi Ltd. K191801 09/13/2019
vexillum zephyr (olifilcon a) with tangible polymers spherical/toric/multifocal silicone hydrogel soft contact lens ; oxypure a (olifilcon a) spherical/toric/multifocal silicone hydrogel soft contact lens Visco Vision Inc K183670 09/13/2019
architect stat high sensitivity troponin-i Abbott Laboratories Diagnostics Division K191595 09/13/2019
arthrex tenodesis button Arthrex Inc. K190288 09/13/2019
juggerstitch meniscal repair device Biomet Inc. K191459 09/13/2019

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