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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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980nm diode laser therapy device Shanghai Apolo Medical Technology Co., Ltd. k191349 08/16/2019
a1at genotyping test Progenika Biopharma S.A., a Grifols Company k171868 11/11/2017
able-x IM-ABLE LTD k120783 06/20/2012
absorbatack 5mm single use absorbable fixation device COVIDIEN k123109 10/23/2012
accessaed, semi-automatic external defibrillators ACCESS CARDIOSYSTEMS, INC. k020984 08/14/2002
accu-chek performa system ROCHE DIAGNOSTICS CORP. k070585 05/25/2007
accuflow and accuflux elastomeric infusion pump Westmed, Inc. k081905 07/15/2008
accuryn monitoring system, accuryn smartfoley iap uo temp tray system 12 f, accuryn smartfoley iap uo temp tray system 14 f Potrero Medical, Inc. k221020 01/13/2023
acoh wellness tester OCCUPATIONAL HEALTH, INC. k823554 01/05/1983
acuson juniper diagnostic ultrasound system Siemens Medical Solutions USA, Inc. k180039 02/01/2018

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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