7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CRYSTAL VISION AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ICE ZIRKON TRANSLUZENT
FDA 510(k)
FDA Class 2
·Dental
RHYTHM DIGITAL ELECTRONIC STETHOSCOPE
FDA 510(k)
FDA Class 2
·Cardiovascular
ACRYSOF IQ TORIC
FDA Adverse Event
Injury
·ALCON RESEARCH LTD./ HUNTINGTON·Product code HQL·January 25, 2013
6000034-2010-00320
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·December 17, 2010
LINOX SD 65/16
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVY·July 14, 2014
BALL TIP GUIDE WIRE 3.2MMX55CM; 469055 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 27, 2018