7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
NIPRO SAFELET CATH
FDA 510(k)
FDA Class 2
·General Hospital
SOMATOM PERSPECTIVE
FDA 510(k)
FDA Class 2
·Radiology
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·December 2, 2010
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·January 14, 2013
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·July 3, 2014
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