4 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
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NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
FDA Enforcement
Class III
·Terminated·Integra LifeSciences Corp.·March 18, 2020
CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteo-arthritis, or post-fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion. This is an uncemented prosthesis designed for press fit use only.
FDA Enforcement
Class III
·Terminated·Integra LifeSciences Corp.·July 3, 2013
The UNI-CP System; Model Number: 330230SND.
FDA Enforcement
Class III
·Terminated·Integra LifeSciences Corp.·March 15, 2017
Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs and other medical materials that will support the administration of spinal anesthesia for use by a surgeon, nurse or other licensed medical professional. Model number is 3403644. The intended use of this tray is to provide the surgeon, nurse or other licensed medical professional, a kit of sterile instruments, drugs and other medical materials that will support the administration of anesthesia, be it local, spinal or general administration.
FDA Enforcement
Class III
·Terminated·Integra LifeSciences Corp. d.b.a. Integra Pain Management·July 11, 2012