10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPECTRALIS with Flex Module
FDA 510(k)
FDA Class 2
·Ophthalmic
24M - Nevada Energy - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588011639·24M - Nevada Energy - Metal
STERIZONE STERILIZER
FDA 510(k)
FDA Class 2
·General Hospital
ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 27, 2023
ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code MTA·November 20, 2008
IAB: 8 FR - 40 CC
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·August 17, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 22, 2013
CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HXX·December 10, 2024
VITEK® 2 GRAM NEGATIVE IDENTIFICATION TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX INC.·Product code LQM·January 24, 2018