12 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EXOTOE LLC
FDA registration
EXOTOE LLC·1 product·🇺🇸 United States
ExoToe
FDA UDI
EXOTOE, LLC·B605EX065·ExoToe Staple 6.5
ExoToe
FDA UDI
EXOTOE, LLC·B605EX070·ExoToe Staple 7.0
ExoToe
FDA UDI
EXOTOE, LLC·B605SZR001·ExoToe Sizing Template 5.5mm, 6.5mm, 7.5mm
ExoToe
FDA UDI
EXOTOE, LLC·B605EX060·ExoToe Staple 6.0
ExoToe
FDA UDI
EXOTOE, LLC·B605EX075·ExoToe Staple 7.5
ExoToe
FDA UDI
EXOTOE, LLC·B605EX055·ExoToe Staple 5.5
ExoToe
FDA UDI
EXOTOE, LLC·B605FCP001·ExoToe Crimping Forceps
EXOTOE STAPLE
FDA Adverse Event
Injury
·EXOTOE, LLC·Product code JDR·August 30, 2022
Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.
FDA Recall
Terminated
·Ebi, Llc·Product code MAX·April 9, 2013
Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the device. Non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion.
FDA Recall
Terminated
·Ebi, Llc·Product code NKB·October 8, 2014
Advanced Bionics HiRes 90K Cochlear Implant, Model: CI-1400-01 and CI-1400-02H, Implant Magnet Case. Cochlear implant intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
FDA Recall
Terminated
·Advanced Bionics LLC·Product code MCM·June 10, 2009