7 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set
FDA 510(k)
FDA Class 2
·Microbiology
HYLATOPIC PLUS EMOLLIENT FOAM
FDA 510(k)
FDA Unclassified
·Unknown
SPACELABS ARKON ANESTHESIA WORKSTATION
FDA 510(k)
FDA Class 2
·Anesthesiology
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE INC.·Product code LZG·October 21, 2014
TRI-LOCK BPS SZ 9 HI OFFSET
FDA Adverse Event
Injury
·1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC·Product code KWA·June 27, 2013
5MM NEEDLE DRIVER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·August 5, 2011
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020