230 results
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9ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.
FDA Enforcement
Class II
·Ongoing·Resource Optimization & Innovation Llc·November 29, 2017
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
Regard, Item Number: 800533002 Sterile, GS0606B - Abdominal PK - Westover Hills
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800527002 Sterile, OR0611B - Hip Shoulder PK - Westover Hills
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800555001, Sterile, HT0644A - Pediatric Card Cath - Childrens Santa Rosa
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800568005, Sterile, OR0658E - Titanium Rib - Childrens Santa Rosa
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: 800551003, Sterile, GS0640C - Lap Chole - Medical Center Santa Rosa
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 880341001, Sterile, GS0775A - Laparoscopic - OSU
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 880327008, Sterile, CV0758H - Open Heart A&B - OSU
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800407003, Sterile, OR0476C - Ortho Pk - Spohn
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800430004, Sterile, LD0499D - C Section Pk - Cabrini
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800528004, Sterile, GS0612D - Lap Chole Pk - Westover Hills
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800411003, Sterile, NU0480C- Neuro PK - Spohn
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highland
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: 800528002 Sterile, GS0612B - Lap Chole PK - Westover Hills
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 880328002, Sterile, HT0759B - Pacemaker Pk - OSU
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800560002, Sterile, GS0649B - Lap Chole - Childrens Santa Rosa
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800526003 Sterile, ET0610C - Head and Neck - Westover Hills
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017