57 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Echosight Jansen-Anderson Intratubal Transfer Set, Catalog Number: K-J-JITS-572900, Global Product Number: G17946 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
FDA Recall
Terminated
·Cook Inc.·Product code MQF·December 19, 2017
Tucker Embryo Catheter, Stylet, For use with Embryo Transfer Catheter, 20 cm, Sterile, Single Use Only, Order #: ftr 220, Manufactured by Fertility Technology Resources, Inc., Marietta, GA 30062
FDA Recall
Terminated
·Fertility Technology Resources, Inc.·Product code MQF·September 13, 2007
Marrs Laparoscopic GIFT Catheters, Catalog Number:K-J-MLC-503000, Global Product Number: G18022 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
FDA Recall
Terminated
·Cook Inc.·Product code MQF·December 19, 2017
Wallace Sure-Pro Two Stage Embryo Replacement Catheter with Obturator PPB623 Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code MQF·March 28, 2013
Wallace Sure-Pro Single Stage Embryo Replacement Catheter Product Code: PP623 Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code MQF·March 28, 2013
Wallace Sure-Pro Ultra Embryo Replacement Catheter with Stylet Product Code:PES623 Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code MQF·March 28, 2013
Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound) Product Code: PE623 Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code MQF·March 28, 2013
Morton IUI Catheter, Sterile, Single Use Only, Order #: ftr510, Manufactured by Fertility Technology Resources, Inc., Marietta, GA 30062
FDA Recall
Terminated
·Fertility Technology Resources, Inc.·Product code MQF·September 13, 2007
Wallace Sure-Pro Two Stage Embryo Replacement Catheter for difficult transfer with Stylet PPS623 Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code MQF·March 28, 2013
Wallace Sure-Pro Ultra Embryo Replacement Catheter with Obturator Product Code: PEB623 Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code MQF·March 28, 2013
Tucker Embryo Catheter with URM Tip, Embryo Transfer Catheter, 23 cm, Order #: ftr123, Manufactured by: Fertility Technology Resources, Inc., Marietta, GA 30062
FDA Recall
Terminated
·Fertility Technology Resources, Inc.·Product code MQF·September 13, 2007
Tucker Embryo Catheter, Stylet, For use with Embryo Transfer Catheter, 23 CM, Sterile, Single Use Only, Order #: ft r 223, Manufactured by Fertility Technology Resources, Inc., Marietta, GA 30062
FDA Recall
Terminated
·Fertility Technology Resources, Inc.·Product code MQF·September 13, 2007
Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.
FDA Recall
Terminated
·Cook Inc.·Product code MQF·October 3, 2019
Tucker Embryo Catheter for Trial Transfer, 20 cm, Order #: ftr320, Manufactured by: Fertility Technology Resources, Inc., Marietta, GA 30062
FDA Recall
Terminated
·Fertility Technology Resources, Inc.·Product code MQF·September 13, 2007
Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity.
FDA Recall
Terminated
·Cook Inc.·Product code MQF·October 3, 2019
Tucker Embryo Catheter with URM Tip, Embryo Transfer Catheter, 20 cm, Order #: ftr120, Manufactured by: Fertility Technology Resources, Inc., Marietta, GA 30062
FDA Recall
Terminated
·Fertility Technology Resources, Inc.·Product code MQF·September 13, 2007
1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number: G19182; 2. Guardia" Access Nano Embryo Transfer Catheter, Catalog Number: K-JETS-551910-L, Global Product Number: G24215; 3. Sydney IVF Embryo Transfer Set, Product Number: K-JETS-7019-SIVF, Global Product Number: G18740
FDA Recall
Terminated
·Cook Inc.·Product code MQF·December 19, 2017
Modular REDAPT(TM) Hip Systems The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity. The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are intended for single use only and are to be implanted without bone cement.
FDA Enforcement
Class II
·Terminated·Smith & Nephew, Inc.·January 11, 2017
Airway Mobilescope MAF-TM
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code EOQ·August 8, 2018
Airway Mobilescope MAF-TM
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·October 10, 2018