66 results
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11ms
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Sources: EU EUDAMED, US FDA
Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·January 22, 2014
ADJUSTABLE DRILL GUIDE, BLACK MAX
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·May 10, 2017
7.2cm Adjustable Drill Guide Product Usage: Electric system
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·May 10, 2017
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
FDA Enforcement
Class II
·Terminated·Flower Orthopedics Corporation·October 13, 2021
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
FDA Enforcement
Class II
·Terminated·QiG Group LLC·March 30, 2016
Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
FDA Enforcement
Class II
·Terminated·QiG Group LLC·March 30, 2016
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)
FDA Enforcement
Class II
·Terminated·QiG Group LLC·March 30, 2016
SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·January 20, 2021
Sterile Nail Clipper Concave Edge (67710)
FDA Enforcement
Class II
·Terminated·Centurion Medical Products Corporation·June 12, 2019
TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.
FDA Enforcement
Class II
·Terminated·Vision RT Ltd·August 31, 2016
Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus (Model #10267000)
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·October 7, 2020
Biograph mCT Flow Edge-4R, Model Number 10528955
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA Inc.·August 12, 2015
SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021
SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021
SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·May 23, 2018
Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr
FDA Enforcement
Class II
·Terminated·Pdg Product Design Group Inc·October 1, 2014
Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definition As (Model #8098027), SOMATOM Definition Edge (Model #10590000), SOMATOM Definition Flash (Model #10430603), SOMATOM Drive (Model #10431700), SOMATOM Confidence (Model #10590100), and SOMATOM Edge Plus (Model # 10267000) with software syngo CT VB20
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·November 20, 2019
SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 31, 2016
C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·August 21, 2013
Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·February 12, 2014