10 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Niobe ES System, Models 001-006000-1 and 001-006100-1
FDA Enforcement
Class II
·Terminated·Stereotaxis Inc·November 18, 2020
Floppy Cronus Endovascular Guidewire, Length 300 cm (partial coat), Diameter 0.014 inch, Part Number 001-001232-4
FDA Recall
Terminated
·Stereotaxis Inc·Product code NFN·January 27, 2004
Niobe ES System, Models 001-006000-1 and 001-006100-1
FDA Recall
Terminated
·Stereotaxis Inc·Product code PJB·September 21, 2020
Cronus Endovascular Guidewire, Length 300 cm (partial coat), Diameter 0.014 inch, Part Number 001-001096-4
FDA Recall
Terminated
·Stereotaxis Inc·Product code NFN·January 27, 2004
Floppy Cronus Endovascular Guidewire, Length 180 cm (partial coat), Diameter 0.014 inch, Part Number 001-001232-3
FDA Recall
Terminated
·Stereotaxis Inc·Product code NFN·January 27, 2004
Cronus-1 Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number 001-001263-1
FDA Recall
Terminated
·Stereotaxis Inc·Product code NFN·January 27, 2004
Cronus Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number 001-001096-1
FDA Recall
Terminated
·Stereotaxis Inc·Product code NFN·January 27, 2004
Cronus Endovascular Guidewire, Length 210 cm (partial coat), Diameter 0.014 inch, Part Number 001-001096-3
FDA Recall
Terminated
·Stereotaxis Inc·Product code NFN·January 27, 2004
OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for: Total Knee Arthroplasty
FDA Recall
Terminated
·OMNI LIFE SCIENCE·Product code OLO·October 14, 2016
Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
FDA Recall
Terminated
·Elekta Inc·Product code HAW·March 30, 2020