19 results
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43ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Irrigation Tubing, 25'; Part Number 5120-25; distributed by Mentor Texas, LP, Irving, TX 75038.
FDA Recall
Terminated
·Mentor Texas, Inc·Product code FPK·April 21, 2008
Autofuse Tubing, DIS SI; Part Number AFTU-DS; distributed by Mentor Texas, LP, Irving, TX 75038.
FDA Recall
Terminated
·Mentor Texas, Inc·Product code FPK·April 21, 2008
Mentor Aseptic Transfer Set, Cat. #350-8400 (contains BD 60mL Luer-Lok Syringe). Aseptic transfer set manufactured by Mentor Texas, LP, Irving, TX 75038 (BD 60 mL Luer-Lok syringe manufactured by Becton Dickinson, Franklin Lakes, NJ 07417).
FDA Recall
Terminated
·Mentor Texas, Inc·Product code GAZ·August 22, 2008
Contour Genesis Inf/IR Tubing; Part Number CG-UT; distributed by Mentor Texas, LP, Irving, TX 75038.
FDA Recall
Terminated
·Mentor Texas, Inc·Product code FPK·April 21, 2008
Lamis Tubing Set, 9'; 10/box; Part Number LAM-TUBING; distributed by Mentor Texas, LP, Irving, TX 75038.
FDA Recall
Terminated
·Mentor Texas, Inc·Product code FPK·April 21, 2008
Hi-Vac Tubing, 8'; 10/box; Part Number B-5558; distributed by Mentor Texas, LP, Irving, TX 75038.
FDA Recall
Terminated
·Mentor Texas, Inc·Product code FPK·April 21, 2008
Contour Genesis Aspiration Tubing, 12'; Part Number CG-PT-5558; distributed by Mentor Texas, LP, Irving, TX 75038.
FDA Recall
Terminated
·Mentor Texas, Inc·Product code BYY·April 21, 2008
Contour Genesis Infiltration Tubing, 13'; Part Number CG-INF-T; distributed by Mentor Texas, LP, Irving, TX 75038.
FDA Recall
Terminated
·Mentor Texas, Inc·Product code FPK·April 21, 2008
Psi-Tec Tubing, 12'; 10/box; Part Number PT-5558; distributed by Mentor Texas, LP, Irving, TX 75038.
FDA Recall
Terminated
·Mentor Texas, Inc·Product code FPK·April 21, 2008
Y Tubing Set, 9'; 10/box; Part Number LAM-Y; distributed by Mentor Texas, LP, Irving, TX 75038.
FDA Recall
Terminated
·Mentor Texas, Inc·Product code FPK·April 21, 2008
Psi-Tec Syringe Pump Infiltration Tubing, 10'; 10/box; Part Number PT-INF-T; distributed by Mentor Texas, LP, Irving, TX 75038.
FDA Recall
Terminated
·Mentor Texas, Inc·Product code FPK·April 21, 2008
MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.
FDA Enforcement
Class II
·Terminated·Mentor Texas, LP.·January 21, 2015
MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.
FDA Enforcement
Class II
·Terminated·Mentor Texas, LP.·September 14, 2016
Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.
FDA Enforcement
Class II
·Terminated·Mentor Texas, LP.·August 10, 2016
MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.
FDA Enforcement
Class II
·Terminated·Mentor Texas, LP.·September 14, 2016
EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product Usage: This product is indicated for single use for temporary insertion intraoperatively to evaluate the volume of the breast implant to be implanted.
FDA Enforcement
Class II
·Terminated·Mentor Texas, LP.·September 10, 2014
Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
FDA Enforcement
Class II
·Terminated·Mentor Texas, LP.·May 17, 2017
CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular implantation and are not intended for use beyond six months.
FDA Enforcement
Class II
·Terminated·Mentor Texas, LP.·September 21, 2016
Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular implantation and are not intended for use beyond six months.
FDA Enforcement
Class II
·Terminated·Mentor Texas, LP.·September 21, 2016