51 results
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14ms
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Sources: EU EUDAMED, US FDA
Filters
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
Tibiaxys Ankle Arthrodesis Plate Compression Guide, Model #159635, part # 159 635, Batch #: EAHZ, EAJ1, ELGV, ENQE & ENQH. Product Usage: The Compression guide is a re-usable instrument used in the implantation of the Tibiaxys product. The Tibiaxys system is intended for fixation of bone fractures or for bone reconstruction (arthrodesis, osteotomies, and fractures of ankle joint, distal tibia and fibula).
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code OYK·November 17, 2011
The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·September 11, 2019
Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
FDA Enforcement
Class II
·Terminated·Flower Orthopedics Corporation·October 13, 2021
6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012