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U.S. Department of Health and Human Services

510(k) Premarket Notification

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71 to 80 of 500 Results *
Decision Date To: 07/22/2019
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colink plating system, fracture and correction system, rts implant system, neospan compression staple system In2Bones USA, LLC K190385 08/08/2019
itotal identity cruciate retaining knee replacement system Conformis, Inc. K190562 08/08/2019
revolution centrifugal blood pump SORIN GROUP ITALIA S.R.L. K190650 08/07/2019
7d surgical system 7D Surgical Inc. K183276 08/07/2019
accurate multi panel drug urine test cup Healstone Biotech Inc K191841 08/07/2019
bonalive granules BonAlive Biomaterials Ltd. K191274 08/07/2019
navigated pedicle access kit IZI Medical Products LLC K191012 08/07/2019
illumisite platform Covidien llc K191394 08/07/2019
elevation spine saber-c system Elevation Spine K190885 08/07/2019
peripheral intravascular lithotripsy (ivl) catheters, ivl generator and connector cable kit, ivl connector cable (replacement) Shockwave Medical, Inc. K191840 08/07/2019

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