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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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flonavi endoscopic fluorescence imaging system Guangdong OptoMedic Technologies, Inc. k221861 02/18/2023
fluoride varnish DENTSPLY INTL. k031932 09/15/2003
fmp coated spiked acetabular cup; hemispherical acetabular cup; flared rim acetabular cup; metal/metal acetabular insert ENCORE MEDICAL, L.P. k063257 11/22/2006
footprint ultra pk suture anchor SMITH & NEPHEW, INC. k113274 03/06/2012
fox pulse oximeter SHUNSUKE NAKANISHI k051736 12/02/2005
freestyle insulinx blood glucose monitoring system ABBOTT DIABETES CARE INC. k120568 03/29/2012
fresenius capd stay.safe disposable administration sets with stay.safe connector FRESENIUS MEDICAL CARE NORTH AMERICA k022412 03/05/2003
fujirebio diagnostics vitamin d control FUJIREBIO DIAGNOSTICS, INC k110641 05/27/2011
gambro polyflux hemodialyzer, model 6h GAMBRO RENAL PRODUCTS k051520 12/09/2005
gamma stick 125-1 tobramycin ria kit ALPHA GAMMA LABORATORY k810011 01/28/1981

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