15 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STAGO FACTOR X-DEFICIENT PLASMA
FDA 510(k)
FDA Class 2
·Hematology
VANCARE, INC.
FDA registration
VANCARE, INC.·2 products·🇺🇸 United States
ONESTEP CPR II MULTI-FUNCTION ELECTRODE
FDA 510(k)
FDA Class 3
·Cardiovascular
BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
1933441-1997-00004
FDA Adverse Event
Product code FSA·June 30, 1997
1933441-1999-00003
FDA Adverse Event
Injury
·Product code FSA·March 13, 2000
1933441-2001-00001
FDA Adverse Event
Death
·Product code FSA·March 5, 2001
1933441-1999-00002
FDA Adverse Event
Injury
·Product code FSA·September 21, 1999
1933441-1997-00005
FDA Adverse Event
Injury
·Product code FSA·December 2, 1997
1933441-2002-00001
FDA Adverse Event
Product code FSA·October 1, 2002
RUNWAY GUIDE CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·May 8, 2013
DURALOC 300 SERIES 58MM OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDL·January 29, 2013
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·December 20, 2010
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·July 14, 2014
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024