9 results
·
34ms
·
Sources: EU EUDAMED, US FDA
CONDUCTIVITY GEL
FDA 510(k)
FDA Class 2
·Neurology
LinkBio Instrument
FDA UDI
Link Bio Corp·00810022403211·LSK Trial Stem Adaptor, Tibial Cone Instrumenta...
LinkBio Instrument
FDA UDI
Link Bio Corp·00810022403228·Pilot Guide Rod Adaptor, Tibial Cone Instrument...
Rubicon 14, 18 and 35 Support Catheters
FDA 510(k)
FDA Class 2
·Cardiovascular
IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01
FDA 510(k)
FDA Class 2
·Immunology
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·June 13, 2014
MINI-CAP, DISCONNECT W/PVP-1SOLUTION
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·October 16, 2010
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·December 13, 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