7 results
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19ms
·
Sources: EU EUDAMED, US FDA
ADEC 1005-C CHAIR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
INSTRUMENT, DENTAL
FDA 510(k)
FDA Class 1
·Dental
DERMIZIP SKIN CLOSURE DEVICE
FDA 510(k)SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·June 10, 2014
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS·Product code LXB·October 11, 2010
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·December 10, 2012
Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
FDA Enforcement
Class I
·Terminated·Cook Inc.·March 2, 2016