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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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Decision
Date
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dinamap advanced nibp module Critikon Company, LLC k000500 05/26/2000
dimension psa flex reagent cartridge Dade Behring, Inc. k003963 02/28/2001
digital fluorographic x-ray system General Electric Co. k833530 11/21/1983
dideco micro 40 ph.i.s.i.o (phosphorylcholine insert surface in oxgenation) newborn/infant arterial filter Cobe Cardiovascular, Inc. k002493 11/30/2000
diamedix is-toxoplasma igm capture test system Diamedix Corp. k001707 07/07/2000
diaclear ultrafilter Gambro Renal Products k003957 11/01/2001
depuy restore orthobiologic soft tissue implant DePuy Orthopaedics, Inc. k001738 12/27/2000
defendo (tm) biopsy valve for olympus(r) and fujinon(r) endoscopes, model 100301, defendo(tm) biopsy valve for pentax(r) Byrne Medical, Inc. k090851 07/02/2009
da vinci xi surgical system (is4000); da vinci x surgical system (is4200) Intuitive Surgical k240723 05/24/2024
d-care surgical face mask 3 ply, d-care medical face mask 3 ply Danameco Medical Joint Stock Corporation k213970 01/23/2022

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