8 results
·
33ms
·
Sources: EU EUDAMED, US FDA
INTELIJET SUCTION SUPPLY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613154183791·BONE GRAFT FIXATION MODULE
POWDERED VINYL EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257
FDA 510(k)
FDA Class 2
·Immunology
OPTIFLUX 160NRE DIALYZER FINISHED ASSY.
FDA Adverse Event
Malfunction
·OGDEN MFG·Product code FJI·January 16, 2013
VIRTUOSO VR
FDA Adverse Event
Malfunction
·MEDTRONIC S.A.·Product code LWS·December 13, 2010
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·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