128 results
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63ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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X-NAV TECHNOLOGIES, LLC.
FDA registration
X-NAV TECHNOLOGIES, LLC.·4 products·🇺🇸 United States
X-GUIDE X-MARK PROBE TOOL
FDA Adverse Event
Malfunction
·X-NAV TECHNOLOGIES, LLC·Product code PLV·October 29, 2021
X-GUIDE SURGICAL NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·X-NAV TECHNOLOGIES, LLC·Product code QRY·November 13, 2024
X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures.
FDA Recall
Terminated
·X-NAV Technologies, LLC·Product code PLV·February 23, 2016
X-Guide Handpiece Adaptor Sleeve 3, Model P010727
FDA Recall
Open, Classified
·X-NAV Technologies, LLC·Product code QRY·March 4, 2024
X-Guide Handpiece Adaptor Sleeve 1, Model P010701
FDA Recall
Open, Classified
·X-NAV Technologies, LLC·Product code QRY·March 4, 2024
X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673
FDA Recall
Open, Classified
·X-NAV Technologies, LLC·Product code QRY·September 28, 2022
X-Guide Handpiece Adaptor Sleeve 3, Model P010727
FDA Enforcement
Class II
·Ongoing·X-NAV Technologies, LLC·April 10, 2024
X-Guide Handpiece Adaptor Sleeve 1, Model P010701
FDA Enforcement
Class II
·Ongoing·X-NAV Technologies, LLC·April 10, 2024
X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures.
FDA Enforcement
Class II
·Terminated·X-NAV Technologies, LLC·April 20, 2016
X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673
FDA Enforcement
Class II
·Ongoing·X-NAV Technologies, LLC·November 16, 2022
X-GUIDE
FDA UDI
XNAV TECHNOLOGIES LLC·00817421021619·HANDPIECE ADAPTOR NUT ASM
X-Guide
FDA UDI
XNAV TECHNOLOGIES LLC·00817421021268·TRACKER ARM ASSEMBLY, EDX, POSTERIOR LL
X-Guide
FDA UDI
XNAV TECHNOLOGIES LLC·00817421021893·X-Guide 3.1.1 Linux Software
X-Guide
FDA UDI
XNAV TECHNOLOGIES LLC·00817421021190·EDX-C TRACKER ARM, LOWER
X-GUIDE
FDA UDI
XNAV TECHNOLOGIES LLC·00817421021558·ADAPTOR SLEEVE - 8
X-GUIDE
FDA UDI
XNAV TECHNOLOGIES LLC·00817421021480·ADAPTOR SLEEVE - 1
X-Guide
FDA UDI
XNAV TECHNOLOGIES LLC·00817421022753·X-Guide 3.5.0 Linux Software
X-Guide
FDA UDI
XNAV TECHNOLOGIES LLC·00817421021220·TRACKER ARM ASSEMBLY, EDX, POSTERIOR UL
X-Guide
FDA UDI
XNAV TECHNOLOGIES LLC·00817421022593·X-Guide 3.4.1 Windows Software