9 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
A3B
FDA 510(k)
FDA Class 1
·Microbiology
NA
FDA UDI
Richard Wolf GmbH·04055207043332·RECTOSCOPE TUBE Ø 19MM WL 261MM WL 261mm, TL 3...
AGILE NAIL
FDA UDI
ORTHOFIX SRL·18056099648967·AGILE NAIL TI LOCKING SCREW L65MM D4MM STERILE
CDI OneView Monitoring System
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO X-PORT DUO PORT
FDA 510(k)
FDA Class 2
·General Hospital
COULTER LH 780 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·May 27, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 15, 2012
0.8% RESOLVE PANEL A
FDA Adverse Event
Injury
·ORTHO CLINICAL DIAGNOSTICS·Product code KSZ·September 14, 2010
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