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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience

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Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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145 records meeting your search criteria returned- Product Code: MKJ Product Problem: No Audible Alarm Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
PHILIPS NORTH AMERICA LLC HS1+ (W G) DEFIB, JAPANESE, EXCHG 06/23/2023
PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL IN EFFICIA DFM100 12/30/2022
ZOLL MEDICAL CORPORATION R SERIES 08/18/2022
PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL IN EFFICIA DFM100 DEFIBRILLATOR/MONITOR 12/24/2021
PHILIPS NORTH AMERICA LLC HEARTSTART XL+ DEFIBRILLATOR/MONITOR 04/07/2021
HEARTSINE TECHNOLOGIES LTD PACKAGE, 500P, 1 PAD-PAK-01, USB, ENGLIS 08/10/2020
PHILIPS MEDICAL SYSTEMS HEARTSTART MRX AIRWORTHY 06/23/2020
HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP03,INTL EN,350-BAS-UK-10 02/13/2020
PHILIPS MEDICAL SYSTEMS HEARTSTART ONSITE 02/05/2020
PHILIPS MEDICAL SYSTEMS HEARTSTART MRX 11/19/2019
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