7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRACE MICROPROTEIN REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AD-HEAR
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
PALL 3N1 FILTER
FDA 510(k)
FDA Class 2
·General Hospital
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - CORK·Product code MCX·January 22, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 14, 2010
QUARTET
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·July 10, 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