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U.S. Department of Health and Human Services

510(K) Premarket Notification
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ortho guidance precision knee software; ortho guidance express knee software; ortho guidance versatile hip software; q guidance system Stryker Leibinger GmbH & Co. KG k233542 03/14/2024
orthadapt bioimplant PEGASUS BIOLOGICS, INC. k071065 05/04/2007
oria cervical plates ORTHOTEC, L.L.C. k023377 03/04/2003
optima ct660 GE MEDICAL SYSTEMS, LLC k110227 07/20/2011
optifix at absorbable fixation system with articulating technology - 30 fasteners, optifix at absorbable fixation system with articulating technology - 15 fasteners C.R. BARD INC. k170278 05/31/2017
one step fsh menopausal test IND DIAGNOSTIC INC. k052662 11/30/2005
omed fabric instrument covers-radiopaq OMEGA-MED INTL., INC. k821334 05/24/1982
olympic warm-up OLYMPIC MEDICAL CORP. k001056 09/29/2000
olea sphere v3.0 OLEA MEDICAL k152602 03/03/2016
nuk expressivetm double electric breast pump MAPA GMBH k121478 04/05/2013

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