8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
GENERAL PURPOSE FLEX COIL
FDA 510(k)
FDA Class 2
·Radiology
MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110
FDA 510(k)
FDA Class 2
·General Hospital
DK-PTCA BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SPRINT
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWS·December 13, 2010
TENDRIL ST
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 9, 2014
EP-4 COMPUTERIZED STIMULATOR
FDA Adverse Event
Injury
·EP MEDSYSTEMS, INC.·Product code JOQ·October 31, 2006
BD ULTRA FINE¿ PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·January 31, 2022
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