8 results
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18ms
·
Sources: EU EUDAMED, US FDA
INCL II ENDOSCOPE
FDA 510(k)
FDA Class 2
·Neurology
CANDELA MODEL MDL-1 LASER LITHOTRIPTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FD EMS, MODEL # D-FJ30E
FDA 510(k)
FDA Class 2
·Physical Medicine
ADVANTA VXT, GDS
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORP.·Product code DSY·January 2, 2013
IAB: 7 FR -30 CC
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·December 21, 2010
STERLING?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·July 29, 2014
Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·November 25, 2015
Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code JDI·October 15, 2015