7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VRT TABLE
FDA 510(k)
FDA Class 2
·Radiology
EBS POWDER
FDA 510(k)
FDA Class 1
·Hematology
DISPOSABLE MICRO-INFUSION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
UNKNOWN
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 22, 2014
UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·November 12, 2012
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·September 2, 2010
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