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Sources: EU EUDAMED, US FDA
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LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878
FDA Enforcement
Class II
·Terminated·Zest Anchors LLC·February 12, 2014
LOCATOR Implant Attachment System. The LOCATOR Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878
FDA Recall
Terminated
·Zest Anchors LLC·Product code DZE·January 16, 2014
ELITE CARE CLINER 6940(STD)/6950(X-LG) w/ Swing Arm products are labeled in part: "****ELITE CARE CLINER 6940/6950***Winco***ISO 9001-2008 Certified***Hassle-free design to optimize your patients comfort***This Elite Care Cliner features dual swing-arms, allowing patients with limited mobility a modified entry. Also, LiquiCell has been added into the seat for extra comfort. This ultra-thin, liquid-filled interface aids in improved blood flow, and helps prevent skin breakdown.***HEAT MASSAGE(Optional)***KEY FEATURES***Dual side swing-arms for modified entry and ease of cleaning***Dual fold down tables***LiquiCell for added comfort***5" nylon total-lock casters***Built-in headrest***Headrest cover***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 334474***www.wincomfg.com***". Sticker with serial number is labeled in part: "***Manufactured By***Winco***Ocala, FL 34474***www.wincomfg.com*** Model No. ***Serial No.***" The Care Cliner is a multi position recliner with a steel frame used primarily in clinics, hospitals and treatment centers for recovery, dialysis, oncology, examination, infusion.
FDA Recall
Terminated
·Winco Mfg., LLC·Product code INM·February 6, 2012
NOCTURNAL ELITE CARE CLINER 6980(STD)/6990(X-LG) products are labeled in part: "***NOCTURNAL ELITE CARE CLINER 6980/6990***Winco***ISO 9001-2008 Certified***An infinite position recliner, independent leg rest and lay-flat all in one chair!***With lay-flat positioning and an independent leg rest, Winco's Nocturnal Elite Care Cliner provides optimal comfort for use in nocturnal dialysis, oncology, acute care and other patient care areas.***HEAT MASSAGE (Optional)***KEY FEATURES***Left side swing-arm for modified entry and ease of cleaning***User-adjustable positioning***Attendant controlled Trendelenburg foot release (on left & right side)***Left side fold down table***Right side Pivot Table***Rear push handle**Lay Flat***Hide-away foot rest***Independent leg rest***LiquiCell for added comfort***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 334474***www.wincomfg.com***". The Care Cliner is a multi position recliner with a steel frame used primarily in clinics, hospitals and treatment centers for recovery, dialysis, oncology, examination, infusion. Sticker with serial number is labeled in part: "***Manufactured By***Winco***Ocala, FL 34474***www.wincomfg.com*** Model No. ***Serial No.***" Note: Model 6988 is a version of the 6980 without the footplate. We have a single, but high volume customer, that requested the chair without the footplate. We put the model in the system so as to call out a specific Bill of Materials to leave off the footplate. Since it was a unique request, there is not a piece of literature for it.
FDA Recall
Terminated
·Winco Mfg., LLC·Product code INM·February 6, 2012
Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LHC·August 25, 2015
regard Item Number 800567001, Sterile, GY0656A - Robotic Hysterectomy - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015
regard Item Number: 800407001, Sterile, OR0476A - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015
regard Item Number: 800514, Sterile, LD0592 - C Section Pack - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015
regard Item Number: 880323, Sterile, LD0754 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015
regard Item Number: 800411002, Sterile, NU0480B - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015
regard Item Number: 800528001, Sterile, GS0612A - Lap Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015
Regard, Item Number: 800558004, Sterile, OR0647D - Extremity - Childrens Santa Rosa
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LRO·January 9, 2017
Regard, Item Number: 800430005, Sterile, LD0499E - C Section Pk - Cabrini
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LRO·January 9, 2017
Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highland
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LRO·January 9, 2017
Regard, Item Number: 800527004 Sterile, OR0611D - Hip Shoulder PK - Westover Hills
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LRO·January 9, 2017
Regard, Item Number: 800567002, Sterile, GY0656B- Robotic Hysterectomy - Alamo
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LRO·January 9, 2017
Regard, Item Number: 800508001, Sterile, LD0586A - C Section - Jasper
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LRO·January 9, 2017
Regard, Item Number: 800555001, Sterile, HT0644A - Pediatric Card Cath - Childrens Santa Rosa
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LRO·January 9, 2017
Regard, Item Number: 880342004, Sterile, GS0776D - Laparotomy - OSU
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LRO·January 9, 2017
Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - Spohn
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LRO·January 9, 2017