7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
NEXXIS OR
FDA 510(k)
FDA Class 2
·Cardiovascular
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·May 30, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
ANIMAS CORPORATION·Product code LZG·January 18, 2013
SELECT SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·December 13, 2010
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