11 results
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7ms
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Sources: EU EUDAMED, US FDA
Karl Storz, Model # 11161C2, Flexible Neuroscope
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·April 1, 2020
Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·April 1, 2020
Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·April 1, 2020
GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations,injections or biopsy.
FDA Enforcement
Class II
·Terminated·GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD·October 30, 2013
TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460
FDA Enforcement
Class II
·Terminated·Quality Electrodynamics LLC·October 9, 2019
TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453
FDA Enforcement
Class II
·Terminated·Quality Electrodynamics LLC·October 9, 2019
TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464
FDA Enforcement
Class II
·Terminated·Quality Electrodynamics LLC·October 9, 2019
TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525
FDA Enforcement
Class II
·Terminated·Quality Electrodynamics LLC·October 9, 2019
TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524
FDA Enforcement
Class II
·Terminated·Quality Electrodynamics LLC·October 9, 2019
TxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829
FDA Enforcement
Class II
·Terminated·Quality Electrodynamics LLC·October 9, 2019
TxRx Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828
FDA Enforcement
Class II
·Terminated·Quality Electrodynamics LLC·October 9, 2019