10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600
FDA 510(k)
FDA Class 2
·Cardiovascular
T2 - NAIL HOLDING SCREW, TIBIA 10 MM
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code LXH·May 21, 2025
T2 - NAIL HOLDING SCREW, TIBIA 10 MM
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code LXH·June 23, 2025
DETECTAR, MODEL N123-MI
FDA 510(k)
FDA Class 1
·Dental
Ochsner Connected Inhaler Sensor
FDA 510(k)
FDA Class 2
·Anesthesiology
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·January 22, 2013
MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-CLONMEL·Product code MAF·December 13, 2010
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
UNKNOWN·Product code ITJ·July 9, 2014
T2 - NAIL HANDLE
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code LXH·May 21, 2025
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