7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VISIBLE-HERPES TM TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
MODELS 841,842,843,851,852 & 853 ELEVATING TRACTIO
FDA 510(k)
FDA Class 1
·Physical Medicine
EMIT QST PHENYTOIN ASSAY -MONOCLONAL ANTIBODY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·June 6, 2014
SELECTSITE DEFLECTABLE CATH
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DQY·October 5, 2010
SL PLUS
FDA Adverse Event
Injury
·SMITH&NEPHEW- SWITZERLAND·Product code KWY·December 3, 2012
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013