7 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALCON CONTACT LENS CASE
FDA 510(k)
FDA Class 2
·Ophthalmic
NONPRESCRIPTION SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
MEDIX BIOTECH IGE VISUAL SCREENING TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
SCREW
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·February 22, 2013
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 31, 2011
SENSOR ENLITE
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OZO·August 1, 2014
Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
FDA Enforcement
Class I
·Terminated·Cook Inc.·March 2, 2016