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U.S. Department of Health and Human Services

510(k) Premarket Notification

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81 to 90 of 500 Results *
Decision Date To: 07/22/2019
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innovasis gibralt spine system Innovasis, Inc. K192354 09/24/2019
inspire 7 hollow fiber oxygenator with integrated hardshell/venous cardiotomy reservoir, inspire 7m hollow fiber oxygenator, inspire 7 dual hollow fiber oxygenator with integrated hardshell/venous cardiotomy reservoir SORIN GROUP ITALIA S.R.L. K190690 04/13/2019
intellamap orion high resolution mapping catheter Boston Scienfitic Corporation K192360 10/25/2019
interlude rolled tampons in plastic applicator ALBAAD fem K191431 10/07/2019
intertape polymer inc., type 1 bismuth process indicator steam sterilization tape Intertape Polymer Inc. K191741 08/02/2019
intra-operative positioning system; simple curve catheter, reverse curve catheter ; angled tip guidewire ; tracking pad ; guidewire handle Centerline Biomedical, Inc. K190106 06/24/2019
intraosseous infusion device Einstein Works, L.L.C. K191258 10/23/2019
intuition-structural heart module TeraRecon Inc. K191585 07/12/2019
ipl home use hair removal device model(s): d-1128, d-1103, d-1119, d-1129, d-1130 Shenzhen Bosidin Technology Co., Ltd. K192432 11/08/2019
juliet® ti ll lumbar interbody device SPINEART K190877 05/29/2019

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