7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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S-ROM ZT HA PROXIMAL FEMORAL SLEEVE
FDA 510(k)
FDA Class 2
·Orthopedic
NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS
FDA 510(k)
FDA Class 2
·General Hospital
Altera Filter and HME/Filter
FDA 510(k)
FDA Class 2
·Anesthesiology
SYMBIQ DUAL CHANNEL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 14, 2014
VIASYS
FDA Adverse Event
Malfunction
·CAREFUSION·Product code CBK·November 19, 2010
ON-Q PAIN PUMP
FDA Adverse Event
Injury
·I-FLOW, LLC·Product code MEB·January 8, 2013
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015