9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SERUM VANCOMYCIN TOXICOLOGY CONTROL
FDA 510(k)
FDA Class 1
·Clinical Toxicology
FIREFLY® Pedicle Screw Navigation Guide
FDA 510(k)
FDA Class 2
·Orthopedic
TRIDENT LARGE DIAMETER ACETABULAR INSERTS
FDA 510(k)
FDA Class 2
·Orthopedic
KAPPA 900 DR
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code DXY·June 10, 2014
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 8, 2010
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·December 10, 2012
LUNA Chest, Model No. LU4006
FDA Recall
Terminated
·Novadaq Technologies, Inc.
13155 Delf Place
Richmond Canada British Columbia·Product code IZI·November 4, 2014
Non-sterile drape
FDA Recall
Terminated
·Novadaq Technologies, Inc.
13155 Delf Place
Richmond Canada British Columbia·Product code IZI·November 4, 2014
V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·October 19, 2016