8 results
·
34ms
·
Sources: EU EUDAMED, US FDA
QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT
FDA 510(k)
FDA Class 2
·Radiology
CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS
FDA 510(k)
FDA Class 2
·Cardiovascular
HARDYDISK CINOXACIN, 100 MCG
FDA 510(k)
FDA Class 2
·Microbiology
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·April 8, 2013
FINELINE II
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·April 6, 2011
VITALITY VR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018