125 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
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regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenience kit
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 30, 2022
regard SHOULDER PACK, GS00125V, Item Number 880120022; ortho surgery convenience kit
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 30, 2022
regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery convenience kit
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 30, 2022
regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery convenience kit
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 30, 2022
regard HAND PACK, OR00594K, Item Number 800243011; ortho surgery convenience kit
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 30, 2022
regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; ortho surgery convenience kit
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 30, 2022
regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kit
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 30, 2022
regard MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenience kit
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 30, 2022
regard SPINE , NU00974F, Item Number 800769006; neuro surgery convenience kit
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 30, 2022
regard SHOULDER, GS00828G, Item Number 880367007; ortho surgery convenience kit
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 30, 2022
regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenience kit
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 30, 2022
regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenience kit
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 30, 2022
regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience kit
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 30, 2022
regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013; general surgery convenience kit
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 30, 2022
regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenience kit
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 30, 2022
Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
FDA Enforcement
Class III
·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 24, 2017
SmartTools Knee System Orthopedic Stereotaxic Instrument
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·April 26, 2017
Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 3, 2017
Navitrack System - OS Knee Universal, Stereotaxic instrument
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 24, 2017
Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components are the central structural column and its base that hold up the computer and the tracking camera on the Sesamoid Plasty workstation. They are also designed to be disassembled such that the column can be folded onto itself for ease of transport after use. This is a retrospective recall report for a removal initiated on 17 June 2008
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·June 14, 2017