13 results
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37ms
·
Sources: EU EUDAMED, US FDA
PARAFFIN INFILTRATION MEDIUM
FDA 510(k)
FDA Class 1
·Pathology
nSpire Health
FDA UDI
NSPIRE HEALTH, INC.·10852417003719·KoKo Standard White Filter Kit with Nose Clip a...
AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 25, 2014
ROTALINK¿ BURR
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code MCX·November 14, 2012
SIMILE
FDA Adverse Event
Injury
·PENTRON CLINICAL·Product code EBF·September 11, 2010
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 20, 2017
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 15, 2017
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 20, 2017
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 11, 2017
G8
FDA Adverse Event
Malfunction
·TOSOH HI-TEC, INC.·Product code PDJ·August 27, 2025
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018