7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
KRONNER UNIVERSAL FRAME EXTERNAL FIXATION
FDA 510(k)
FDA Class 2
·Orthopedic
epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test
FDA 510(k)
FDA Class 2
·Clinical Chemistry
N LATEX RF KIT
FDA 510(k)
FDA Class 2
·Immunology
INTERSTIM
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code EZW·June 13, 2014
PUMP MMT-522NAL PRDGM INS V2.2 CL EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·October 12, 2010
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 12, 2012
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