10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Codman Certas Plus Programmable Valve; Codman Certas Toll Kit
FDA 510(k)
FDA Class 2
·Neurology
FORZA SPACER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PLAQUEVIEW SOFTWARE, MODEL CSPV-0001A
FDA 510(k)
FDA Class 2
·Radiology
MEDTRONIC SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC WORLD HEADQUARTERS·Product code LKK·December 10, 2013
UNKNOWN KNEE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code NRA·July 22, 2015
PROMUS PREMIER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·October 6, 2014
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·May 29, 2013
OCTRODE LEAD, 30CM LENGTH
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 23, 2011
BD MAX¿ ENTERIC BACTERIAL PANEL
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCI·October 12, 2023
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015