8 results
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19ms
·
Sources: EU EUDAMED, US FDA
HEPA 2500 AIR CLEANER
FDA 510(k)
FDA Class 2
·General Hospital
Intuitive Workflow Tools
FDA UDI
Barco NV·05415334002050·accessories for image enhancement in diagnostic...
ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE
FDA 510(k)
FDA Class 2
·Hematology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 28, 2013
ACCU-CHEK MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·December 16, 2010
LANCET DEVICE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·July 12, 2014
Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·May 16, 2018