9 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LifeFlow Blood System
FDA 510(k)
FDA Class 2
·General Hospital
Sonic
FDA UDI
Sonic Innovations, Inc.·05711583032092·ET40 MNR T, 2.4G NFM DPB TP ENCHANT 40
POLARIS URETHRAL STENT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code FAD·May 10, 2007
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
FDA 510(k)
FDA Class 1
·General Hospital
CERAMIC PEDATRIC PREFORMED CROWN
FDA 510(k)
FDA Class 1
·Dental
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 21, 2014
ETS FLEX ARTICNG LNR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 26, 2013
RENAISSANCE 26
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·July 28, 2011
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