35 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic and pediatric surgical procedures.
FDA Enforcement
Class II
·Terminated·Ethicon Endo-Surgery Inc·May 27, 2015
TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue retraction during a surgical procedure.
FDA Enforcement
Class II
·Terminated·Abeon Medical Corporation·January 27, 2016
TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retraction of soft tissue away from the operative surface.
FDA Enforcement
Class II
·Terminated·Abeon Medical Corporation·January 27, 2016
Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY. Indicated to aid in tissue retraction during a surgical procedure.
FDA Enforcement
Class II
·Terminated·Abeon Medical Corporation·January 27, 2016
Regard, Item Number: 800411002, Sterile, NU0480B- Neuro PK - Spohn
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - Spohn
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800533001, Sterile, GS0606A - Abdominal Pk - Westover Hills
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 880327006, Sterile, CV0758F - Open Heart A&B - OSU
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800559001, Sterile, ET0648A - Head & Neck - Childrens Santa Rosa
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 880328001, Sterile, HT0759A - Pacemaker Pk - OSU
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800558001, Sterile, OR0647A - Extremity - Childrens Santa Rosa
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800527003 Sterile, OR0611C - Hip Shoulder PK - Westover Hills
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800419001, Sterile, GY0488A - D&C Pk - Spohn
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - Spohn
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800415002, Sterile, OR0484B- Shoulder System Pk - Spohn
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800567002, Sterile, GY0656B- Robotic Hysterectomy - Alamo
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800414002, Sterile, OR0483B- Total Joint Pk - Spohn
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800524003, Sterile, LD0608C - C Section - Westover Hills
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800418002, Sterile, GY0487B - Major Vaginal Pk - Spohn
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800623001, Sterile, NU0787A - Neuro - Medical Center Santa Rosa
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017