8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DEBUSK TEMP. SYST. ESOPHAGEAL STETHOSCOPE
FDA 510(k)
FDA Class 2
·Anesthesiology
B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER
FDA 510(k)
FDA Class 2
·Radiology
FRANKLIN 9000 WALL STAND
FDA 510(k)
FDA Class 2
·Radiology
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·October 6, 2023
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 17, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 22, 2013
CAPSURE SP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 14, 2010
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