7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PCA MODULAR TOTAL KNEE-UNIVERSAL TIBIAL BASEPLATE
FDA 510(k)
FDA Class 2
·Orthopedic
PERIMETER SUMP DRAIN
FDA 510(k)VACU-PREP
FDA 510(k)LIBERTY CYCLER SET, SINGLE CONN./EXT.DL
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·June 2, 2014
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code KRG·October 19, 2010
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 16, 2012
SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, 459801585212.
FDA Enforcement
Class I
·Ongoing·Philips North America Llc·July 3, 2024