3 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).
FDA Enforcement
Class II
·Terminated·Captiva Spine, Inc·April 29, 2015
Depuy P.F.C. E Knee System, stabilized plus tibial insert; polyethylene tibial insert, Sz 4, 20 mm; Ref 96-2744.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005
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