7 results
·
22ms
·
Sources: EU EUDAMED, US FDA
TILT SEATING SYSTEM
FDA 510(k)
FDA Class 1
·Physical Medicine
SURGITRON 4.0 DUAL RF S5-IEC
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS
FDA 510(k)
FDA Class 2
·Anesthesiology
CELL-DYN SAPPHIRE ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·December 13, 2010
R3
FDA Adverse Event
Injury
·SMITH&NEPHEW, INC.·Product code JDI·January 22, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 9, 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