9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE
FDA 510(k)
FDA Class 2
·Cardiovascular
A16 BLOOD FLOW MEASUREMENT SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
VECTEC DISPOSABLE MONOPOLAR CONNECTOR CABLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNK
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HRS·April 7, 2026
UNK
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HRS·April 7, 2026
HUDSON VOLDYNE 2500 VOLUMETRIC EXCERCISER
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BWF·May 14, 2013
PARADIGM REAL-TIME REVEL INSUILN INFUSION PUMP
FDA Adverse Event
MEDTRONIC PUERTO RICO OPERATION CO·Product code OYC·September 26, 2014
KAPPA 700 DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code DXY·June 14, 2011
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