12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COAMATE PROTEIN C CHROMOGENIC ASSAY
FDA 510(k)
FDA Class 2
·Hematology
Alpine SL
FDA UDI
Rmo, Inc.·00885797714572·BIO ALPINE SL BRACHYFACIAL 018 HK/3 5-5 20 EA
RADIUS MICRO SNARE
FDA 510(k)
FDA Class 2
·Cardiovascular
PROTURA COUCH SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
CADD
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·September 28, 2020
OPTIFLUX F250NRE DIALYZER
FDA Adverse Event
Malfunction
·OGDEN MANUFACTURING·Product code KDI·May 23, 2014
SYNVISC (HYLAN G-F 20) INJECTION
FDA Adverse Event
Other
·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·January 14, 2013
ATTAIN OTW
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010
CADD ADMINISTRATION SET
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·August 12, 2020
CADD ADMINISTRATION SET
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·August 12, 2020
CADD ADMINISTRATION SET
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·August 12, 2020
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