8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BRANEMARK SYSTEM SINGLE TOOTH ABUTMENTS,INST&COMP.
FDA 510(k)
FDA Class 2
·Dental
COULTER DART ALT (GPT) REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MODEL 143 SERIES BLOOD PRODUCT IRRADIATORS
FDA 510(k)
FDA Unclassified
·Unknown
BASIS¿ SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC·Product code KWP·July 19, 2012
SIGMA 300 SR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·December 14, 2010
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 22, 2013
TENDRIL ST
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