7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BECKMAN LIQUID-STAT MAGNESIUM REAGENT & STANDARD
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CVA
FDA 510(k)
FDA Class 1
·Microbiology
ENZYGNOST BETA-2 MICROGLOBULIN TEST
FDA 510(k)
FDA Class 2
·Immunology
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code FSA·June 19, 2014
ONE TOUCH PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·June 10, 2009
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·December 21, 2012
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014