7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
BRANEMARK SYSTEM SELF-TAPPING FIXTURE
FDA 510(k)
FDA Class 2
·Dental
POOLE TIP SUCTION PROBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GEN-PROBE LUMINOMETER-LEADER 450
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CAPSURE SP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 14, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·January 22, 2013
ISOFLEX OPTIM LEAD
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·July 10, 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