108 results
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11ms
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Sources: EU EUDAMED, US FDA
Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of calculi.
FDA Recall
Open, Classified
·Northgate Technologies, Inc.·Product code FFK·October 25, 2021
microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.
FDA Recall
Open, Classified
·FHC, Inc.·Product code HAW·October 4, 2024
Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code JAK·March 26, 2026
Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code JAK·March 26, 2026
Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code JAK·March 26, 2026
Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code JAK·March 26, 2026
Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code JAK·March 26, 2026
Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code JAK·March 26, 2026
Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code JAK·March 26, 2026
Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KRD·February 20, 2024
WALLFLEX FC ESO STENT RMV LL 23X105- Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516300
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code ESW·August 1, 2024
WALLFLEX FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516310
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code ESW·August 1, 2024
WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516740
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code ESW·August 1, 2024
WALLFLEX FC ESO STENT RMV 23X125MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516250
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code ESW·August 1, 2024
WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516260
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code ESW·August 1, 2024
WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516920
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code ESW·August 1, 2024
WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516270
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code ESW·August 1, 2024
WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516230
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code ESW·August 1, 2024
WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516710
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code ESW·August 1, 2024
WALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516930
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code ESW·August 1, 2024