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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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berlex bolus/infusion(tm) intravenous admin set Venusa , Ltd. k905518 06/21/1991
betaject bd u100 Orange Medical Instruments, Inc. k833705 05/09/1984
bimetric total hip system Biomet, Inc. k921224 02/16/1994
biodentine Septodont k140132 06/27/2014
biological ohm meter, bes 200z Bioelectrical Sciences, Inc. k880926 06/15/1988
biomoneta avata rx Biomoneta Research Private Limited k251872 11/14/2025
bion hsv1-g or hsv2-g test system Bion Ent., Ltd. k881261 06/07/1988
bioshield biopsy valve (00711124); bioshield biopsy valve (00711125); bioshield biopsy valve (00711126); bioshield biopsy valve (00711127); bioshield biopsy valve (00711129); bioshield biopsy valve (00711135); bioshield biopsy valve (00711136); bioshield biopsy valve - sterile (00711128); bioshield irrigator (00711133); bioshield irrigator (00711137); bioshield irrigating adaptor (00711131); bioshield irrigator - extension tubing (00711134) Steris k232951 10/20/2023
biotis cooked meat Otisville Biotech, Inc. k860410 02/24/1986
blue powder free nitrile examination glove with grape scented, chemotherapy drugs and fentanyl test claim Riverstone Resources Sdn Bhd k220672 06/03/2022

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