9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
MONOJET SAMPLETTE ADAPTERS
FDA 510(k)
FDA Class 1
·Hematology
TSRH SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 3, 2013
LOW PROFILE CROSSLINK SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 30, 2015
TERUMO TCM II COOLING AND HEATING SYSTEM
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DWC·March 27, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code CGA·November 14, 2012
ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·September 13, 2010
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026