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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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Applicant
Sort by PMA Number [0-9]
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510(K)
Number
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Decision
Date
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transpara 1.7.0 Screenpoint Medical B.V. k210404 06/02/2021
trojan(r) extra str latex condom w/sperm sili lubr Armkel, LLC k904000 02/19/1991
tubulitec primer Dental Therapeutics AB k851052 07/31/1985
ultrack total knee system Wrightmedicaltechnologyinc k953439 01/30/1996
ultrasonic scalpel system Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. k212614 07/18/2022
uni npwt foam dressing kit, uni npwt foam dressing kit, uni npwt foam dressing kit Blue Ocean Medical Product, LLC k133333 12/31/2014
unicor, inc. connectors & airway extensions Unicor, Inc. k953786 09/19/1995
unifit femoral stem Osteo Technology, Inc. k922871 02/12/1993
united wound covering, package of 5 United Medical k863389 11/17/1986
uric acid reagent Ac Biochemical Laboratories, Inc. k822913 12/20/1982

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