7 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code CEC·April 23, 2012
Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AURAGEN CORTICAL SURFACE ELECTRODES
FDA 510(k)
FDA Class 2
·Neurology
5.5MM TI CANCELLOUS LOCKING SCREW
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MQP·January 26, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 5, 2014
CUSTOM PACK
FDA Adverse Event
Malfunction
·ALCON - BELGIUM·Product code KYG·December 17, 2004