9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
UB ANALYZER, MODEL UA-1/REAGENT KIT/BILIRUBIN CON.
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ORTHOSOURCE
FDA UDI
ORTHOSOURCE·D9118711150·Superb Light Wire
ORTHOSOURCE
FDA UDI
ORTHOSOURCE·D911871115G0·Superb Light Wire with Groove
MODIFICATION TO BILOK ST SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
3D Endo Software
FDA 510(k)
FDA Class 2
·Radiology
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·June 13, 2014
FENESTRATED BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·December 12, 2012
PRINEO SKIN CLOSURE SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OMD·June 26, 2015
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020