9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA
FDA 510(k)
FDA Class 2
·Cardiovascular
Dolder® System
FDA UDI
Cendres+Métaux SA·07640166514107·Dolder® System
Spacer macro
UNK
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC.·Product code KNS·June 13, 2014
KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60
FDA 510(k)
FDA Class 2
·Dental
DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PROMUS ELEMENT ¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·April 11, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 12, 2011
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·May 20, 2008
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014