3,359 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STELLA CONTACTS
FDA Adverse Event
Injury
·UNKNOWN·Product code LPL·August 11, 2023
Shiley FlexTra brand Flexible Dual-Cannula Tracheostomy Tube, Models: 358060, Size 6, FlexTra Cuffed; 358070, Size 7, FlexTra Cuffed; 358080, Size 8, FlexTra Cuffed; 358090, Size 9, FlexTra Cuffed; 358100, Size 10, FlexTra Cuffed; 359060, Size 6, FlexTra Uncuffed; 359070, Size 7, FlexTra Uncuffed; 359080, Size 8, FlexTra Uncuffed; 359090, Size 9, FlexTra Uncuffed; 359100, Size 10, FlexTra Uncuffed, Tyco Healthcare/Nellcor is currently responsible for Research and Development for this product. Tyco Healthcare/MMJ S.A. De C.V., Cuidad Juarez, Mexico manufactures the FlexTra Tracheostomy Tube. The product is sterilized at Sterigenics, located at Santa Teresa, New Mexico.
FDA Recall
Terminated
·Nellcor Puritan Bennett·Product code JDH·December 9, 2004
CONTOUR
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDH·October 28, 2016
REDAPT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDH·October 24, 2016
TNDM BP SHL/XLPE LNR 41OD 26ID
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDH·October 25, 2016
TANDEM BIPOLAR SHELL/XLPE LINER 42MM OD 26MM ID
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDH·October 25, 2016
HIP PROSTHESIS
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC.·Product code JDH·August 14, 2015
HIP PROSTHESIS SCREW
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDH·September 8, 2015
HIP PROSTHESIS
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDH·August 12, 2015
HIP PROSTHESIS
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDH·July 17, 2015
REF FSO 5 50MM OD
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDH·July 15, 2015
SYNERGY
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC·Product code JDH·February 27, 2012
1020279-2012-00073
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC·Product code JDH·February 7, 2012
FEMORAL COMPONENT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDH·January 26, 2012
UNKNOWN
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDH·January 4, 2012
1020279-2012-00182
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC·Product code JDH·March 21, 2012
BIPOLAR
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDH·February 6, 2012
FEMORAL COMPONENT
FDA Adverse Event
Injury
·BROOKS MANUFACTURING SITE·Product code JDH·March 27, 2012
REFLECTION
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDH·January 23, 2012
TANDEM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDH·February 2, 2012