7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CHEM-CHEX
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EQUINOX RELIEVE
FDA 510(k)
FDA Class 2
·Anesthesiology
NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER
FDA 510(k)
FDA Class 2
·Dental
ESSURE
FDA Adverse Event
Injury
·CONCEPTUS, INC·Product code HHS·June 30, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·January 14, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·November 22, 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