18 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TRANSTEK WRIST BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564033130·Basic Pack
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450192689·
MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER CONTROL, DADE CARDIAC TL LOW LEVEL LIQUID ASSAYED CARDIAC MA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)
FDA 510(k)
FDA Class 2
·Cardiovascular
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973295·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970690·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970676·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970645·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970621·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970638·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970683·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970652·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970669·
IMPLANTED TRIFUSION CATHETER
FDA Adverse Event
Malfunction
·C. R. BARD INC. (BASD)·Product code LJS·May 15, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 26, 2014
CAPSURE SENSE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 14, 2011
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024