5 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Niobe ES System, Models 001-006000-1 and 001-006100-1
FDA Enforcement
Class II
·Terminated·Stereotaxis Inc·November 18, 2020
Niobe ES System, Models 001-006000-1 and 001-006100-1
FDA Recall
Terminated
·Stereotaxis Inc·Product code PJB·September 21, 2020
Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. Catalog Number: 5100-060-001
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code HBF·October 16, 2020
Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. Catalog Number: 5100-060-001
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·November 18, 2020
MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715
FDA Enforcement
Class II
·Terminated·Megadyne Medical Products, Inc.·August 22, 2018