8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDCOMP PERITONEAL DIALYSIS CATHETERS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFIED MONITORING SYSTEM MODELS M1175A & M1176A
FDA 510(k)
FDA Class 2
·Cardiovascular
LAPAROSCOPE SUPPORT ARM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LIFEPAK 20
FDA Adverse Event
Injury
·PHYSIO-CONTROL INC.·Product code MKJ·January 9, 2013
SITTER SELECT
FDA Adverse Event
Malfunction
·J. T. POSEY CO.·Product code KMI·February 25, 2014
ARTERIAL CATH SET: 20 GA X 8
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DQX·November 5, 2010
BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 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