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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
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510(K)
Number
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Decision
Date
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allen medullary cement plugs, zimmer poly plug intramedullary system, model 8011 series & 1109 & 8109 series Zimmer, Inc. k001733 06/20/2000
zimmer trabecular metal reverse shoulder system Zimmer, Inc. k133378 05/12/2014
zimmer arthroscopy system Zimmer, Inc. k811596 06/25/1981
ha anatomic hip prosth w/ti-nidium surf hard proce Zimmer, Inc. k925607 11/08/1993
therma-h Zewa AG k921189 08/31/1992
zynergy featherpace transvenous bipolar catheter, model 04-x-02-3-10-3 Zcv ,Inc. k002481 12/07/2000
zynergy z3k balloon guided pacing and monitoring catheter Zcv ,Inc. k010099 02/01/2001
ysi model 2300 stat plus Ysis, Inc. k913806 10/02/1991
dental cone beam computed tomography system Yofo Medical Technology Co., Ltd. k243337 04/17/2025
laser 20 Ya-Man, Ltd. k011021 10/09/2001

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