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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 56 Results
productcode MKJ PMA Number p Decision Date From 1/1/2020 Decision Date To 1/1/2021
 
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zoll stat-padz ii electrodes and zoll pedi-padz ii... ZOLL MEDICAL CORPORATION P160015 S008 12/30/2020
zoll cpr uni-padz ZOLL MEDICAL CORPORATION P160015 S009 12/30/2020
zoll aed 3 ZOLL MEDICAL CORPORATION P160015 S007 12/21/2020
heartstart fr3 defibrillator PHILIPS MEDICAL SYSTEMS, INC. P160028 S003 12/16/2020
heartstart onsite defibrillator, and heartstart ho... PHILIPS MEDICAL SYSTEMS, INC. P160029 S007 12/16/2020
heartstart frx defibrillator Philips Medical Systems P180028 S004 12/16/2020
x series, r series, and aed pro ZOLL MEDICAL CORPORATION P160022 S023 12/07/2020
samaritan public access automated external defibri... HeartSine Technologies, Ltd. P160008 S015 11/18/2020
defibtech automated external defibrillator (aed) s... DEFIBTECH, LLC P160032 S003 11/18/2020
defibtech automated external defibrillator (aed) s... DEFIBTECH, LLC P160032 S009 10/23/2020
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