9 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EMIT-BARBITURATE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198451·AK3 Ultra Insert Trial Size 1, 14mm
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123083·K-WIRE - DOUBLE TROCAR 1.1mm DIA x 100mm
Game Ready GRPro 2.1 System
FDA 510(k)
FDA Class 2
·Physical Medicine
FIAX C4 ASSAY
FDA 510(k)
FDA Class 2
·Immunology
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 8, 2014
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 11, 2012
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 10, 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