12 results
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19ms
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Sources: EU EUDAMED, US FDA
ACA VANCOMYCIN (VANC) METHOD
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Vyaire
FDA UDI
Jaeger Medical GmbH·14250892903009·Nose clip
Jaeger
FDA UDI
Jaeger Medical GmbH·14250892901135·Nose Clip
Qty: 1 pack of 10
Jaeger
FDA UDI
Jaeger Medical GmbH·14250892907007·Nose clip
H500 Multi-Sensing Oximetry System
FDA 510(k)
FDA Class 2
·Cardiovascular
EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM
FDA 510(k)
FDA Class 2
·Orthopedic
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 2, 2019
DEXCOM G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 6, 2015
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 2, 2013
CURLIN 6000
FDA Adverse Event
Malfunction
·MOOG·Product code FRN·November 1, 2010
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 27, 2020
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015