7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
CURELLE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
WALLACH COLD SOAKER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MICROLINE SCREEN FOR OPIATES
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ASTRAL 150 - DEU
FDA Adverse Event
Malfunction
·RESMED LTD·Product code NOU·July 10, 2015
CONSTELLATION VISION SYS
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·February 26, 2014
IAB : 8 FR - 40 CC FOS
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·November 5, 2010
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