3 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·January 7, 2015
REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·March 19, 2014
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·March 21, 2018