7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ORS-1000
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG
FDA 510(k)
FDA Unclassified
·Unknown
MEMFIX SCREWS
FDA 510(k)
FDA Class 2
·Dental
HEARTMATE APICAL SEWING RING
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·June 5, 2014
ARTERIAL CATH SET: 20 GA X 8
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DQX·November 5, 2010
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·January 9, 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