7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXAC-TEMP & CLINI-TEMP TYMPANIC & MYOCARDIAL PROBE
FDA 510(k)
FDA Class 2
·General Hospital
SOFTCUP(TM):2
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DOCUMENT CK ISOENZYMES CONTROL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VERSA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NVZ·December 14, 2010
OT ULTRA EASY METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·January 22, 2013
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