8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ONE-LUNG CPAP DEVICE
FDA 510(k)
FDA Class 2
·Anesthesiology
HARDY DISK CLARITHROMYCIN, 15MCG
FDA 510(k)
FDA Class 2
·Microbiology
FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE
FDA 510(k)
FDA Class 2
·Anesthesiology
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 30, 2014
5 FR TL POWERPICC MAX TRAY, TLS
FDA Adverse Event
Malfunction
·C. R. BARD INC. (BASD)·Product code LJS·January 4, 2013
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·November 17, 2010
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023