6 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Cervical Tray Catalog 1089
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022
Lumbar Tray Catalog 1091
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022
Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).
FDA Enforcement
Class II
·Terminated·Captiva Spine, Inc·April 29, 2015
Stryker PCD Precision System 13G Needle with Spineplex, sterile, single use, disposable , 4 units per box. units per box. Stryker Instruments, Kalamazoo, MI Part Number: 0505-585-000, Lot:11223012 13G Match Ground Four facet Tip Introduction Needle - PIN 0306-130-011 13G Bevel Tip Stylet - PIN 0306-131-012 The intended use of the Stryker PCD System is for mixing bone cement and delivering it percutaneously. Bone cement is mixed in the chamber then transferred directly into an extension nozzle which has been attached to the introduction needle in the fracture site by a luer lock fitting. Cement is then dispensed directly into the fracture site under fluoroscopy
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code JDZ·November 30, 2011
Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system particularly suited for institutions with immobile or hardly mobile patients, such as trauma wards and emergency departments. The system s versatility also makes it suitable for unified diagnostic imaging services for medium size hospitals where this system can cover all diagnostic radiography needs. In general, Vision systems are intended to position the patient, x-ray source and digital detector in such a way as to expose only the desired patient anatomy to X-rays and capture the resulting x-ray image. They are then intended to process the acquired image to a diagnostic viewing level and export it in DICOM format through an option of several distribution media including film, paper, CD-DVD and digital PACS archives. The system is intended for routine, daily, dedicated use in radiographic diagnosis. It can be used in any type of specialized radiology wards or for general radiographic diagnostics
FDA Enforcement
Class II
·Terminated·Visaris DOO·May 23, 2018
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015