7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ISOTRAK AMYLASE TEST AMYLASE ISOENZYME
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIFEVEST WCD 3100 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·January 15, 2013
CONTAK RENEWAL
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·January 10, 2011
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CALI·Product code KDI·July 23, 2014
GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·July 30, 2014