7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
TINA-QUANT [A] TRANSFERRIN
FDA 510(k)
FDA Class 2
·Immunology
Feminine Personal Trainer (FPT)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FOX 940, MODEL 940
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SETROX S 53
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·June 13, 2014
FLEXTEND II
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·October 16, 2010
UNKNOWN RIGHT KNEE STRYKER
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·December 6, 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