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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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510(K)
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fiberstitch implant, curved with two polyester implants and 2-0 fiberwire, fiberstitch implant, straight with two polyester implants and 2-0 fiberwire T.A.G. Medical Products Corporation, Ltd K190125 05/19/2019
qiastat-dx respiratory panel QIAGEN GmbH K183597 05/18/2019
cardiogard emboli protection cannula CardioGard Medical Ltd K182302 05/17/2019
wizard 310/320 series cpap mask Apex Medical Corp. K182394 05/17/2019
irestore professional 282 Freedom Laser Therapy, Inc. K183417 05/17/2019
navigation enabled instruments STRYKER K183381 05/17/2019
soft-pass embryo mock transfer catheter sets (soft-pass embryo mock transfer catheter set and soft-pass embryo mock transfer catheter set with echogenic tip) Cook Incorporated K191015 05/17/2019
delta xtend reverse shoulder system DePuy (Ireland) K183077 05/17/2019
dimension exl high-sensitivity troponin i (tnih) assay Siemens Healthcare Diagnostics, Inc. K190675 05/17/2019
drx-revolution mobile x-ray system Carestream Health Inc. K191025 05/17/2019

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