7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXAC-TEMP & CLINI-TEMP PROBE W/TEMPERATURE SENSOR
FDA 510(k)
FDA Class 2
·General Hospital
CORITAXIC MULTI-MODAL STEREOTAXI WORKSTATION
FDA 510(k)
FDA Class 2
·Neurology
GYROSCAN S15/ACS-II
FDA 510(k)
FDA Class 2
·Radiology
PULSE GEN MODEL 104
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·July 20, 2015
SM104 MSERIES W5TH WHL
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIV·Product code FPO·November 23, 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