8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
AMERLITE PROLACTIN-30 ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
INNERVUE INSTRUMENTATION CASE
FDA UDI
Biomet Orthopedics, LLC·00880304480056·
INNER-LOCK LOCKING INTRODUCER SHEATHS
FDA 510(k)
FDA Class 2
·Cardiovascular
SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION
FDA 510(k)
FDA Class 2
·Orthopedic
HEARTMATE 14V POWER MODULE PATIENT CABLE
FDA Adverse Event
Malfunction
·THORATEC CORP.·Product code DSQ·January 16, 2013
VIRTUOSO VR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·December 13, 2010
RESOLUTE INTEGRITY RX
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NIQ·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