176 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
FDA Recall
Terminated
·Flower Orthopedics Corporation·Product code HRS·September 3, 2021
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
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
SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code JAK·November 24, 2020
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
Edge Nuclear Magnetic Resonance Imaging System. "1.5T Edge High-Field Magnetic Resonance Imaging System, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143, U.S.A.".
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code LNH·September 19, 2008
DeVilbiss Model DV5x Series CPAP with Heated Humidifier Device is intended to treat Obstructive Sleep Apnea (OSA) in patients weighing 30 Kg and above. The device creates a positive pressure in the patient's airway to prevent collapse of the airway while the patient is sleeping. The heated humidifier provides additional humidity to the air supplied to the patient. The heated humidifier has a removable water chamber for filling with water and ease of cleaning.
FDA Recall
Terminated
·Sunrise Medical HHG Inc. dba DeVilbiss Healthcare·Product code BZD·March 11, 2011
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
Sterile Nail Clipper Concave Edge (67710)
FDA Recall
Terminated
·Centurion Medical Products Corporation·Product code PWC·March 29, 2019
Biograph mCT Flow Edge-4R, Model Number 10528955
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA Inc.·August 12, 2015
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 Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code JAK·June 22, 2020
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 Recall
Terminated
·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016
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
Biograph mCT Flow Edge-4R, Model Number 10528955
FDA Recall
Terminated
·Siemens Medical Solutions USA Inc.·Product code KPS·July 14, 2015