8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
NEUROSTIM II
FDA 510(k)
FDA Class 2
·Anesthesiology
SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028
FDA 510(k)
FDA Class 2
·Cardiovascular
ATRIUM FLIXENE IFG VASCULAR GRAFT
FDA 510(k)
FDA Class 2
·Cardiovascular
TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158
FDA 510(k)
FDA Class 2
·Orthopedic
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 20, 2014
PULSAR GENERATOR
FDA Adverse Event
Malfunction
·MEDTRONIC ADVANCED ENERGY LLC·Product code GEI·October 25, 2012
LINOX SMART S DX 65/17
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVY·June 5, 2015
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