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U.S. Department of Health and Human Services

510(k) Premarket Notification

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101 to 110 of 500 Results *
Decision Date To: 07/22/2019
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iassist knee system Orthosoft Inc. (d/b/a Zimmer CAS) K192080 11/05/2019
koala IB Lab GmbH K192109 11/05/2019
powder free vinyl patient examination gloves, clear (non-colored) Anhui Powerguard Technology Co.,Ltd K191292 11/05/2019
tap blood collection device Seventh Sense Biosystems, Inc. K190225 11/05/2019
adi tidal osteotomy wedge Additive Device, Inc. (ADI) d/b/a restor3d K191047 11/05/2019
platelet and plasma separator for bone graft handling: Fidia PRP Kit fidia farmaceutici s.p.a. BK180296 11/05/2019
suglue 3 3M Deutschland GMBH K192992 11/05/2019
mei ceramic bracket Orthosun Co., Ltd. K190608 11/04/2019
drx-evolution/plus with dual energy Carestream Health, Inc. K190330 11/04/2019
ethanzir zirconia Besorah Dental Solutions NZ Limited K191304 11/04/2019

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