7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SURFFLASH(R) PLUS SAFETY I.V. CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
T2 SUPRACONDYLAR NAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·November 9, 2010
TPS HANDPIECE CORD
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·July 9, 2014
ICY CATHETER
FDA Adverse Event
Malfunction
·ALSIUS CORP.·Product code NCX·August 28, 2006
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