7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
I-STOP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Respiratory Gating for Scanners
FDA 510(k)
FDA Class 2
·Radiology
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code DXY·February 9, 2013
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·January 6, 2011
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CALI·Product code KDI·July 23, 2014
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025