13 results
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24ms
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Sources: EU EUDAMED, US FDA
MORPHEUS
FDA 510(k)
FDA Class 2
·Dental
NIGHTRON POLYSOMNOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
CLS SPOTORNO STEM
FDA 510(k)
FDA Class 2
·Orthopedic
PRECISION?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 5, 2026
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·April 29, 2013
TSH, THYROTROPIN
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JLW·May 9, 2011
POWERFLEX P3 PTA DILATATION CATHETER
FDA Adverse Event
Injury
·CORDIS EUROPA, N.V.·Product code LIT·July 24, 2008
BD PHOENIX¿ AST BROTH
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·December 2, 2022
BD PHOENIX¿ AST INDICATOR SOLUTION
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·December 2, 2022
1.5MM DIA DRILL BIT W/6MM STOP 13MM LENGTH F/90° SCREWDRIVER
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code DZI·May 19, 2015
Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172
FDA Enforcement
Class II
·Terminated·Vision RT Ltd·October 10, 2018
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
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018