7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
ABUSCREEN RADIOIMMUNOASSAY FOR BENZODIAZEPINES
FDA 510(k)
FDA Class 2
·Clinical Toxicology
FURNACE AUTOSAMPLER, MODEL 155
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EAGLE + ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 13, 2014
TALENT STENT GRAFT SYSTEM WITH XCELERANT - HYDRO
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·October 8, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·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