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Sources: EU EUDAMED, US FDA
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Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tulip in order to create a spinal fixation construct. The Set Screw is provided to the user non-sterile and is used across three Biomet Spine product lines; Silverton Spinal Fixation System (Silverton), Silverton-D Spinal Fixation System (Silverton-D) and Telluride Minimally Invasive Spinal Fixation System (Telluride). The primary packaging for the Set Screws is an aluminum sterilization case that holds both implants and instruments used collectively as part of a system. Additionally, Set Screws can be packaged in a heat sealed polypropylene bag for single device distribution.
FDA Enforcement
Class II
·Terminated·Biomet Spine, LLC·March 4, 2015
Sinu-Lift(TM) System, LLC., Model SLS-1, Sterile, Innovative Implant Technology, The Sinu-Lift(TM) System is intended to : - Facilitate access to the maxillary sinus, - Lift the sinus membrane from the alveolar ridge of the maxilla with a minimum height of 5mm, and - Augment the space created by lifting the maxillary sinus membrane with bone graft to supplement the maxillary alveolar crest with additional height needed for anchoring an implant.
FDA Recall
Terminated
·Innovative Implant Technology·Product code NDP·September 30, 2008
Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.
FDA Recall
Terminated
·Ebi, Llc·Product code MAX·April 9, 2013
Sgarlato Labs GAIT (Great Toe Implant Technique) Implant-- Large, Product Number 30-100-03 Large, Manufactured by Sgarlato Med LLC, San Jose, CA
FDA Recall
Terminated
·Sgarlato Med, LLC·Product code KWH·March 1, 2009
SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
FDA Recall
Terminated
·Implant Direct Sybron Manufacturing LLC·Product code NHA·January 9, 2019
Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tulip in order to create a spinal fixation construct. The Set Screw is provided to the user non-sterile and is used across three Biomet Spine product lines; Silverton Spinal Fixation System (Silverton), Silverton-D Spinal Fixation System (Silverton-D) and Telluride Minimally Invasive Spinal Fixation System (Telluride). The primary packaging for the Set Screws is an aluminum sterilization case that holds both implants and instruments used collectively as part of a system. Additionally, Set Screws can be packaged in a heat sealed polypropylene bag for single device distribution.
FDA Recall
Terminated
·Biomet Spine, LLC·Product code NKB·November 30, 2012
Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,
FDA Recall
Terminated
·Implant Direct Sybron Manufacturing LLC·Product code DZE·October 11, 2019
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX080603CD; Edwards Lifesciences LLC, Irvine, CA 92614.
FDA Recall
Terminated
·Edwards Lifesciences, Llc·Product code FGE·December 5, 2007
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX090603CD; Edwards Lifesciences LLC, Irvine, CA 92614.
FDA Recall
Terminated
·Edwards Lifesciences, Llc·Product code FGE·December 5, 2007
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060403CD; Edwards Lifesciences LLC, Irvine, CA 92614.
FDA Recall
Terminated
·Edwards Lifesciences, Llc·Product code FGE·December 5, 2007
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100403CD; Edwards Lifesciences LLC, Irvine, CA 92614.
FDA Recall
Terminated
·Edwards Lifesciences, Llc·Product code FGE·December 5, 2007
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070603CD; Edwards Lifesciences LLC, Irvine, CA 92614.
FDA Recall
Terminated
·Edwards Lifesciences, Llc·Product code FGE·December 5, 2007
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100901CD; Edwards Lifesciences LLC, Irvine, CA 92614.
FDA Recall
Terminated
·Edwards Lifesciences, Llc·Product code FGE·December 5, 2007
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070301CD; Edwards Lifesciences LLC, Irvine, CA 92614.
FDA Recall
Terminated
·Edwards Lifesciences, Llc·Product code FGE·December 5, 2007
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070401CD; Edwards Lifesciences LLC, Irvine, CA 92614.
FDA Recall
Terminated
·Edwards Lifesciences, Llc·Product code FGE·December 5, 2007
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100801CD; Edwards Lifesciences LLC, Irvine, CA 92614.
FDA Recall
Terminated
·Edwards Lifesciences, Llc·Product code FGE·December 5, 2007
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060203CD; Edwards Lifesciences LLC, Irvine, CA 92614.
FDA Recall
Terminated
·Edwards Lifesciences, Llc·Product code FGE·December 5, 2007
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100201CD; Edwards Lifesciences LLC, Irvine, CA 92614.
FDA Recall
Terminated
·Edwards Lifesciences, Llc·Product code FGE·December 5, 2007
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100903CD; Edwards Lifesciences LLC, Irvine, CA 92614.
FDA Recall
Terminated
·Edwards Lifesciences, Llc·Product code FGE·December 5, 2007
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060301CD; Edwards Lifesciences LLC, Irvine, CA 92614.
FDA Recall
Terminated
·Edwards Lifesciences, Llc·Product code FGE·December 5, 2007