7 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARGENCO 52HN
FDA 510(k)
FDA Class 2
·Dental
LATEX PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
ADD'L DATA E-SP MULTIPURPOSE EPIDURAL SPINALNEEDLE
FDA 510(k)
FDA Class 2
·Anesthesiology
PRM PB W/YLW KEY SC 3CLV BC AND OL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·May 29, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 9, 2013
NI
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWQ·November 19, 2010
HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013