8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PERSONNEL PROTECTIVE SHIELD
FDA 510(k)
FDA Class 1
·Radiology
ANEROID SPHYGMOMETER
FDA 510(k)HEARING AID, UNITRON MODEL 761P
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
ICON 25 HCG (COMBO CASSETTE)
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHI·April 16, 2014
VITALITY
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 15, 2010
NEXGEN CR-FLEX GSF FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·December 6, 2012
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
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023