28 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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PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options.
FDA Recall
Terminated
·Dako North America Inc.·Product code PLS·February 2, 2018
TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453
FDA Recall
Terminated
·Quality Electrodynamics LLC·Product code MOS·August 20, 2019
TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460
FDA Recall
Terminated
·Quality Electrodynamics LLC·Product code MOS·August 20, 2019
TxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829
FDA Recall
Terminated
·Quality Electrodynamics LLC·Product code MOS·August 20, 2019
TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524
FDA Recall
Terminated
·Quality Electrodynamics LLC·Product code MOS·August 20, 2019
TxRx Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828
FDA Recall
Terminated
·Quality Electrodynamics LLC·Product code MOS·August 20, 2019
TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464
FDA Recall
Terminated
·Quality Electrodynamics LLC·Product code MOS·August 20, 2019
TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525
FDA Recall
Terminated
·Quality Electrodynamics LLC·Product code MOS·August 20, 2019
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 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524
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 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
TxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scanners to produce diagnostic images of the knee that can be interpreted by a trained physician.
FDA Enforcement
Class II
·Terminated·Quality Electrodynamics LLC·September 12, 2012
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 Recall
Terminated
·GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD
No. 2 Yong Chang North Rd.
Beijing Econ. & Tech. Dev. Zone
Beijing China·Product code OXO·September 18, 2013
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
ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the following: PROSUN ONYX 32 SLI INTENSIVE RED, PROSUN ONYX 32 SLI INTENSIVE PEARL WHITE, ANYTIME FITNESS ONYX 32 SLI INTENSIVE BRONZE, PROSUN ONYX 32 SLI INTENSIVE BRONZE Tanning of the skin
FDA Recall
Terminated
·ProSun International, LLC·Product code LEJ·December 10, 2018
ConMed Laparoscopic Instrument: Babcock Disposable Grasper, 5mm x 43cm length, REF/Product Code 60-6047-431. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility.
FDA Recall
Terminated
·Conmed Corporation·Product code GEJ·October 12, 2006