7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SARNS 7850 CENTRIFUGAL PUMP (MODIFIED)
FDA 510(k)
FDA Class 2
·Cardiovascular
MEGA DRESSING CHANGE KIT
FDA 510(k)
FDA Class 2
·General Hospital
FIXATION STAPLE
FDA 510(k)
FDA Class 2
·Orthopedic
X3 TRIATHLON CS INSERT #7 13MM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS LIMERICK·Product code JWH·November 17, 2010
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 7, 2014
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·December 28, 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