7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COAG-CONTROL [N] KIT
FDA 510(k)
FDA Class 2
·Hematology
PEDIATRIC POSITIONER PAD SET
FDA 510(k)
FDA Class 1
·Radiology
MODIFICATION TO CARDEON AEGIS CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
IAB: 7.5 FR - 30 CC
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·January 16, 2013
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·December 13, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 9, 2014
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