3 results
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8ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections. Indiciated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
FDA Enforcement
Class II
·Terminated·American Optisurgical Inc·June 27, 2012
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016
Philips Zenition 50, Model Number: 718096
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024