3 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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Bard Stinger Ablation Catheter: Item Numbers 210001 218501 L210001 210002 218502 L210002 210003 218503 L210003 210004 218504 L210004 210005 218505 L210005 210006 218506 L210006 210007 218507 L210007 210015 218516 L210008 210016 218518 L210009 210017 218519 L210010 210018 218520 L210011 210019 218521 L210012 210020 218523 L210013 210023 218524 L210014 210024 218525 L210015 210025 218526 L210016 210026 218527 L210017 210027 218528 L210018 210028 218529 210029 210030
FDA Recall
Terminated
·C. R.Bard, Inc./Electrophysiology Division·January 8, 2003
Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·July 24, 2019
i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K 001387
FDA Enforcement
Class II
·Terminated·Abbott Point Of Care Inc.·July 18, 2012