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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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510(K)
Number
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Decision
Date
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counter 700 & hc-700 hemo 0 ref. Hycel, Inc. k771107 07/11/1977
xia spine system Howmedica Osteonics Corp. k002505 10/05/2000
modular replacement system cemented stems Howmedica Osteonics Corp. k040749 06/17/2004
stryker and serf hip devices Howmedica Osteonics Corp (Dba Stryker Orthopaedics) k250989 07/25/2025
urotopo catheter Houston Biomedical, Inc. k861200 04/23/1986
portable, battery operated defibrillator Honeywell, Inc. k810237 02/19/1981
hms neuromuscular stimulator, model hms 3 Home Medical Services k003231 01/12/2001
passive tendon implant Holter-Hausner Intl. k780320 03/17/1978
hollister skin barrier a Hollister, Inc. k810709 04/07/1981
miplatform medical imaging suite v3.0 (miplatform v3.0), miplatform zfp viewer Hinacom Software and Technology, Ltd. k171977 08/02/2018

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