7 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BRANEMARK SYSTEM TEMPORARY SOLUTIONS
FDA 510(k)
FDA Class 2
·Dental
MODEL 109 SERIES BLOOD PRODUCTS IRRADIATORS
FDA 510(k)
FDA Unclassified
·Unknown
DRAINAGE TUBE RESTRAINT/WOUND COVER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
EMERGE¿
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·January 22, 2013
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIV·Product code FPO·November 23, 2010
TENDRIL STS
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·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