2 results
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11ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket
FDA Enforcement
Class II
·Terminated·Keystone Dental Inc·May 2, 2018
IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. The IPC POWEREASE System is also used in the placement of screws, or cutting of screws, posts, and rods. The IPC is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.
FDA Enforcement
Class II
·Ongoing·Medtronic Xomed, Inc.·September 3, 2025